U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
X-ray system - Product Code JAA
Cause
X-ray systems could provide output which exceeds the 20 r/minute limit.
Action
Consignees were notified by certified letter on 08/14-15/2006.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Staple, implantable - Product Code GDW
Cause
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Action
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Plate, bone - Product Code JEY
Cause
The recalling firm has confirmed that the outer plate component exhibits an excessive chamfer on the threading after deburring operations. this excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
Action
Zimmer Biomet sent an Urgent Medical Device Recall letter dated April 5, 2018, to Distributors, Sales Representatives, and Distribution Managers. A separate recall letter was sent to Risk Managers on the same date.
Consignees were informed of the product issue and risk of non-functioning device and delays in surgery. All parties were instructed to review the notice, locate and quarantine affected product in inventory, return all affected product with a completed return form and mark "RECALL" on the outside of returned cartons, and return the completed customer response form.
If you have further questions or concerns regarding this recall, please call (904)741-4400 extension 9133 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a voicemail prompt. For further questions, please call (574) 371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. the cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Action
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) LOT SPECIFIC" letter dated 8/7/17 to its Customers. The letter described the product, problem and actions to be taken. The Distributors were instructed to:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form and Attachment 3 Certificate of Decontamination to Zimmer Biomet.
a. For each return, send a copy of Attachment 1 and Attachment 2 to corporatequality.postmarket@zimmerbiomet.com.
b. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
c. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL.
5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate that no additional users have been identified.
6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility.
7. If after reviewing this notice you have further questions or concerns please call the customer call center at (574) 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergen
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. the cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Action
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) LOT SPECIFIC" letter dated 8/7/17 to its Customers. The letter described the product, problem and actions to be taken. The Distributors were instructed to:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form and Attachment 3 Certificate of Decontamination to Zimmer Biomet.
a. For each return, send a copy of Attachment 1 and Attachment 2 to corporatequality.postmarket@zimmerbiomet.com.
b. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
c. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL.
5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate that no additional users have been identified.
6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility.
7. If after reviewing this notice you have further questions or concerns please call the customer call center at (574) 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergen
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
X-ray - Product Code JAA
Cause
X-ray systems could provide output which exceeds the 20 r/minute limit.
Action
Consignees were notified by certified letter on 08/14-15/2006.