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.
Advance(r) ha coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Action
MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days.
For questions regarding this recall call 901-867-4771.
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.
Advance(r) ha coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Action
MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days.
For questions regarding this recall call 901-867-4771.
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.
Advance(r) ha coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Action
MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days.
For questions regarding this recall call 901-867-4771.
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.
Advance(r) ha coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Action
MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days.
For questions regarding this recall call 901-867-4771.
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.
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Action
The firm sent an Urgent Product Recall letter dated May 26, 2016 to customers, via email and FedEx Overnight delivery . The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Inspect inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately.
2. Complete the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form.
3. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return.
4. Return any affected product to the address listed on the Inventory Return Certification Form. Indicate the RA number on your return shipment.
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.
Through the investigation of reported complaints integra verified that there have been instances where the universal wire fixation bolts the slotted post broke during use at the surgical site.
Action
Integra sent an Urgent - Voluntary Medical Device Recall letter dated July 20, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Integra is asking you to take the following actions:
1. Please check your Integra¿ External Fixation System inventory to determine if you have the 17.5mm or 23mm Universal
Wire Fixation Bolts and/or the large or small Slotted Posts.
2. If you do have 17.5mm or 23mm Universal Wire Fixation Bolts and/or large or small Slotted Posts, stop using them immediately.
3. Complete the attached "Acknowledgement and Return Form" and check the box: I do have affected products on the list and record the lot number.
4. Or, complete the attached "Acknowledgement and Return Form" and check the box: I do not have affected products.
5. Complete the other information as indicated on this form. Keep a copy of the form for your records.
Return the completed "Acknowledgement and Return Form" by email or fax indicating your receipt and review of this notification.
When your form is received, if you have noted you have affected products, an Integra Representative will contact you and provide you with directions to return the product, as well as input an order to replace the quantity you indicated on the form.
Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and signed copy of the acknowledgement form for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action.
Should you have any questions regarding these instructions, please contact Sales Operations at 888-601-0203, option 2. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
Fo
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
Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Cause
Sterility compromised due to breach in sterile packaging.
Action
Smith & Nephew issued recall letters via Federal Express on July 19, 2016 to the customers. Customers asked to inspect inventory and locate any unused devices, and quarantine immediately. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return.
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
Screw, fixation, bone - Product Code HWC
Cause
Labeling does not match the cleared indications for use in the united states and canada.
Action
DePuy Synthes initiated a Field Safety Notice to remove the affected Technique Guides and marketing literature from the field. Sales Consultants and Synthes Trauma Marketing will receive training on affected technique guides and marketing literature which promoted off label use. All technique guides and literature have been put on hold and removed from DePuy Synthes website. Effectiveness of this field action will be tracked using their training system. They will confirm training when completed as a means to measure effectiveness.
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.
Advance(r) ha coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Action
MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days.
For questions regarding this recall call 901-867-4771.
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.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
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
Screw, fixation, bone - Product Code HWC
Cause
Labeling does not match the cleared indications for use in the united states and canada.
Action
DePuy Synthes initiated a Field Safety Notice to remove the affected Technique Guides and marketing literature from the field. Sales Consultants and Synthes Trauma Marketing will receive training on affected technique guides and marketing literature which promoted off label use. All technique guides and literature have been put on hold and removed from DePuy Synthes website. Effectiveness of this field action will be tracked using their training system. They will confirm training when completed as a means to measure effectiveness.
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.
Labeled with the incorrect global trade item number (gtin). the gtin on the label identifies the devices as another.
Action
Exatech sent an Important Notification letter dated May 16, 2016, to all affected customers. The letter notified customers of the product's incorrect Global Trade Item Number. Customers were instructed to cease distribution/use of the product, extend the information to accounts possessing the recalled product, identify and quarantine any devices in inventory, and to complete and return the Recall Inventory Response Form acknowledging that they received the recall notification. Customers were instructed to call 800-392-2832 with any questions. For questions regarding this recall call 352-377-1140.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Cause
As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
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.
Zimmer biomet spine initiated a recall of certain solitaire ti spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.
Action
Zimmer Biomet sent an Urgent Medical Device Recall Notice letter dated February 26, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed Response Form. For questions call 303-465-8929.
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.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Cause
Zimmer bioment spine, inc. announces a voluntary field action for the zyston¿ transform instrument case and zyston¿ transform implant kit because the locking mechanism on the implant is not functioning as intended.
Action
Verbal notification of the decision to recall the product and related instructions was provided on June 30, 2016. Additionally, written notification of the decision to recall the product and related instructions will be provided to each of the individuals responsible for locations that have affected inventory under their control. Clear instructions and materials necessary to support the accountability and retrieval of product from the field will be provided with the recall notification. In order to ensure that the locations were alerted of the recall in a timely fashion, supplemental email notifications will also be sent to each recall notification addressee before distributing the recall documentation via Federal Express.
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.
Stryker orthopaedic is voluntarily recalling the triathlon modular handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
Action
Stryker sent an Urgent Product Recall letter dated June 24, 2016 to Branches/Agencies by e-mail and Business Reply Forms was sent to Branches/Agents/Hospital Risk Management via UPS (with return receipt) on June 24, 2016. The letter identified the affected product, problem and actions to be taken. For questions call (201) 831-6693.
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.
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the specialty triathlon tibial alignment handle with secondary lock assembly during surgery. upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
Action
Stryker sent an Urgent Product Recall letter dated June 24, 2016, with a Business Reply Form attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Product Recall letter and forward the notice to all those individuals who need to be aware within their organization. Customers were instructed to return all affected product at their location to:
Stryker C/O Stericycle
2670 Executive Dr., Suite A
Indianapolis, IN 46241
Customers were also instructed to complete and sign the enclosed Business Reply Form and fax it to 888-912-7352 or email to Stericycle at strykerortho4582@stericycle.com. Customers with questions were advised to call (201) 831-6693.
For questions regarding this recall call 201-831-5000.
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.
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Action
Smith & Nephew sent an Urgent Product Recall Notification letter dated July 6, 2016, to all affected consignees via email and FedEx Overnight delivery on July 6, 2016. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were asked to inspect their inventory and located any unused affected devices and quarantine them immediately, complete the Inventory Return Certification Form and fax to 1-901-566-7975 indicating the quantities that need to be returned. Consignees should contact Smith & Nephew's Field Actions Department via email at FieldActions@smith-nephew.com to obtain a return authorization (RA) number.
For questions regarding this recall call 901-399-5520.
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.
Stryker has received reports in which the cutting blocks have fractured on impaction during surgery.
Action
Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated August 30, 2010, to all consignees/customers (branches/agencies, hospital risk management, hospital Chief of Orthopaedics, surgery) including foreign countries. The letter described the product, problem, and action to be taken by customers. The customers were instructed to complete and return the attached PRODUCT RECALL ACKNOWLEDGMENT FORM via fax to 201-831-6069.
If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance (201) 972-2100.
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.
Stryker has received reports in which the cutting blocks have fractured on impaction during surgery.
Action
Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated August 30, 2010, to all consignees/customers (branches/agencies, hospital risk management, hospital Chief of Orthopaedics, surgery) including foreign countries. The letter described the product, problem, and action to be taken by customers. The customers were instructed to complete and return the attached PRODUCT RECALL ACKNOWLEDGMENT FORM via fax to 201-831-6069.
If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance (201) 972-2100.
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
Cement, bone, vertebroplasty - Product Code NDN
Cause
The piston head can become separated from the delivery piston, blocking the injection assembly valve resulting in a cement backflow towards the injector handle. potential for delay in surgery if additional cement needs to be prepared for the injection procedure.
Action
On 6/13/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier and sales representatives via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments:
Jennifer Olson
269-389-2644
jennifer.olson@stryker.com
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.
The screw may fracture at the junction of the shaft and the head during implantation. the patient may retain a foreign body if the fractured screw cannot be removed. soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. a delay in surgery less than 30 minutes may occur.
Action
Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 10, 2016, to all affected customers via courier. Distributors and hospitals were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-6725, Monday through Friday, 8 a.m. to 5 p.m.
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
Reamer - Product Code HTO
Cause
The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. testing found that if the cutting edge is missing, the reamer will not perform as intended.
Action
The firm, BIOMET, sent an" URGENT MEDICAL DEVICE RECALL NOTICE" dated December 23, 2010 to its customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to immediately locate, discontinue use of product and return the product to Biomet. Biomet distributors were told to notify hospital personnel of the recall if they had distributed the product to hospital customers. The Customers/Distributors were instructed to confirm receipt of the notice by calling 800-348-9500 extension 3755 and 3983 and to complete and return the Response Form included with the recall notice via fax to 574-372-1683.
Questions related to this notice should be directed to 574-371-3755 or 574-372-3983, Monday through Friday, 8am to 5pm.
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.
Zimmer biomet initiated a voluntary recall of the twist drill & v-tek twist drill due to to a potential tolerance stack up identified between the twist drill and the mating kirschner wire (k-wire) component.
Action
Zimmer GmbH initiated a voluntary recall of the Normed - TWIST DRILL Cannulated & Normed- V-TEK TWIST DRILL Cannulated, with written notices on June 27, 2016 via certified mail due to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. Customers are asked to do the following: Review the notification and ensure affected personnel are aware of the contents.
2. Locate all affected product identified above and quarantine them immediately.
3. Return any affected product within your possession. Clearly mark the outside of all return packages,
Recall, and include a copy of the Inventory Return Certification form (Attachment 1) with your return
shipment(s).
4. If after reviewing this notification you have further questions or concerns please call the customer
call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
" Online:www.fda.gov/medwatch/report.htm
" Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to address on the pre-addressed form.
" Fax: 1-800-FDA-0178
Affected units returned as part of this recall activity will be scrapped