German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: greatbatch medical standard offset cup impactor
the united states food and drug administration (fda) has issued a medical device safety alert concerning standard offset cup impactor manufactured by greatbatch medical. the affected device was manufactured from january 2004 through january 2013 and distributed from january 2004 through december 2013.
the manufacturer has identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use provided with the device. the manufacturer has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (aami st79 standard). customers who have the affected product should immediately begin utilizing the new sterilization instructions.
for details, please refer to the following fda websites:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1119-2014&w=03122014&lang=eng
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm388928.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm389005.Htm
http://www.Fda.Gov/safety/recalls/ucm388883.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 13 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: depuy lps (limb preservation system) lower extremity dovetail intercalary component
it has come to our attention that the medical device manufacturer, depuy orthopaedics, inc. has initiated a field safety corrective action concerning its lps (limb preservation system) lower extremity dovetail intercalary component. the affected part number is 1987-19-055.
according to the manufacturer, the affected product has the potential for fracture of the female component when exposed to certain physiological loads. bench testing simulating loads under normal walking conditions demonstrated that patients over approximately 200 lbs. (90 kg) are at higher risk and that increasing weight may pose increasing risk. however, common activities such as stair ascent and descent and rising from chairs may exert forces higher than those under normal walking conditions. other factors such as the patient’s musculature, activity level, and overall health should also be considered.
the possible clinical implications related to this issue, which could only occur if the product should fracture, include:
poor mechanics and loss of function
pain
dislocation: the separation of the male component from the female component
adverse tissue reaction if the broken piece of the female component were to completely break free and cause irritation to the surrounding tissue.
damage to bone in areas that are important for revision surgery. surgeon may be unable to conduct revision surgery due to lack of sufficient bone stock, potentially resulting in amputation if no other therapeutic options remain available.
the clinical implications above may lead to revision surgery.
depuy provides the following advice to the affected customers:
customers are advised to stop further distribution or use of the affected products immediately for use in primary surgery.
depuy is not recommending prophylactic revision in the absence of symptoms. however, surgeons are encouraged to communicate with patients who received these implants as deemed appropriate (considering weight and activity level).
depuy recommends that surgeons review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors.
if a patient presents with a fractured lps lower extremity dovetail intercalary component with well‐fixed proximal and distal stems and the surgeon determines that the lps lower extremity dovetail intercalary component is the best treatment option, the company will make the lps lower extremity dovetail intercalary component available.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 july 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: zimmer m/l taper with kinectiv technology femoral stems and necks
the united states food and drug administration (fda) has issued medical device safety alerts concerning m/l taper with kinectiv technology femoral stems and necks, manufactured by zimmer.
the manufacturer has initiated a voluntary recall of 64 lots (752 implants total) of m/l taper with kinectiv femoral stems and modular necks due to higher than allowed cytotoxicity levels found with the product.
the manufacturer found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. these residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. use of these products may require the need for a revision surgery to replace the affected implant.
according to the local supplier, the affected products are not distributed in hong kong.
for details, please refer to the fda websites:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1699-2015&w=06172015&lang=eng
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm452012.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451936.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 june 2015.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and the Czech Republic.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Sweden.
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.
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.
Signal Medical sent a Notice letter dated September 30, 2014 to customers. Customers were instructed to carefully inspect devices to ensure package integrity before using. If packaging is compromised it should not be used. Return the affected device and packaging to Signal Medical Corporation. Replacement devices with new packaging configuration is shipped to each location with the old packaging configuration in the event that the packaging is found to be compromised. For questions contact Signal Medical Corp. at 1-800-246-6324.
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
Product is mislabeled.
Action
4Web Medical sent an Urgent Medical Device Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The firm does not require any action to be performed by the consignees.The firm plans to label the remaining recalled lot not distributed as , "samples".
Please contact 4Web Customer Service for questions and support.
Phone: (1-800) 285-7090
Hours: Monday through Friday, 8:00am to 5:00pm Central Standard time.
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
appliance, fixation, spinal intervertebral body - Product Code KWQ
Cause
The packaging of 4.5 mm diameter maxan screws identifies/labels the screws as 4.0 mm diameter screws.
Action
Zimmer Biomet Spine sent an Urgent Medical Device Recall Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
If the device has already been implanted, written confirmation of this will be required and the necessary parties will be contacted. They will store returned product in quarantine in an isolated location until they can undergo inspection to verify if they are conforming or not and then will be destroyed or retained. Necessary parts will be destroyed so that it is visually obvious they are no longer functional. For further questions call (303) 443-7500 ext.244.
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, fixation, bone - Product Code HRS
Cause
The 2.7mm/3.5mm va-lcp humerus plates were found to be labeled incorrectly. part number 02.117.410s was incorrectly etched with part number 02.117.610s.
Action
The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 9/28/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to
" Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s).
" Complete the Verification Section (page 3 of this letter), (even if you do not have the product) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided.
" Return the Verification Section (page 3 of this letter) with the product to:
" Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
" Send a copy of the completed Verification Section by:
" Fax: 844-294-7175 or
" Scan/email: Synthes4672@stericycle.com
" Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification.
If you have any questions, please call 610-719-5450.
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.
Eight (8) pieces did not receive the specified hydroxyapatite (ha) coating.
Action
The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email kaya@exac.com. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative.
Any questions contact your Exactech inventory representative at kaya@exac.com or 1-800-392-2832.
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 is recalling various lots of the trithion mis modular distal capture because complaints were received that specific lots of this product may disassociate during use.
Action
Stryker notified their Branches/Agencies of this recall by email on September 29, 2015 and notifiction letters and product accountability forms were sent via UPS (with return receipt) on September 29, 2015 to branches and on September 30, 2015 to hospitals. Stericycle wil be handling the returns. Customers with questions were instructed to call 201-831-5826.
For questions regarding this recall call 201-831-5272.
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 spine is recalling radius rod to rod connector 5.5 to 3.5 mm (catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.
Action
Stryker Spine initiated this recall by sending an "Urgent Product Removal Letter and Product Accountability Form dated September 25, 2015 to the Branch Manager, Agency Manager, Quality Contact via FedEx priority overnight.
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
Patient specific manual orthopedic stereotaxic system - Product Code OSF
Cause
Potential inaccuracies in the alignment of the guides. surgery was inaccurately planned because the patient image data was incorrectly processed.
Action
On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature
Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was
followed up by e-mail notification letter with response forms.
Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be
Customer Service
Materialise USA LLC
44650 Helm Court
Plymouth, Michigan 48170
734-259-7033
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 integrated fixation, cervical - Product Code OVE
Cause
Incorrect external and internal packaging labels. exactech has identified nineteen (19) acapella one interbody fusion device lordotic (05-090-01-1610) were packaged as acapella one interbody fusion device parallel (05-090-02-1610).
Action
Exactech sent a recall notification letter dated September 28, 2016 to their only 2 consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately cease distribution or use of these products, extend this information to accounts that have this products in their possession, identify and quarentine any of the product and complete and return the attached recall inventory response form to Exactech. Contact: Kaya Davis at Kaya@exac.com or 1-800-392-2832
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.
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Action
On September 23, 2016, Becton Dickinson sent a Field Safety Notice to all affected customers describing the details of the recall and necessary action to take.
ACTIONS TO BE TAKEN BY BD:
A credit will be applied to your account for the affected product upon receipt of the affected unit(s) or receipt of certification of destruction documented on the customer response form.
Complete the Recall Response form certifying that all affected product in your inventory has been destroyed and mail/email a copy of the response form.:
The firm requests customers to promptly return the enclosed response form to expedite the correction process and acknowledge receipt of this notification.
Or email: GMB-GLB¿VMFieldActions@carefusion.com For further questions, please call (847) 473-1500.
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
Stabilized Tibial Insert - Product Code NJL
Cause
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Action
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Cause
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Action
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Cause
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Action
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Cause
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Action
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Cause
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Action
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Cause
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Action
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Cause
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Action
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.