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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Notas adicionales en la data
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Mismarked and unmarked screws.
Acción
On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Notas adicionales en la data
Photocoagulator and accessories - Product Code HQB
Causa
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Acción
Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Notas adicionales en la data
Screwdriver - Product Code HXX
Causa
Potential for set screw to be come deformed.
Acción
Spine Frontier sent an Urgent Advisory Notice letter dated May 30, 2013 to all affected consignees. The letter identified the affected product. problem and actions to be taken. The letter informed consignees that a correction was implemented for InSpan Inserters. Consignees were instructed to remove parts from the field immediately for modification and that replacement Inserters will be shipped upon receipt of completed acknowledgement form and RMA request for part return. For questions call 978-232-3990.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Notas adicionales en la data
Photocoagulator and accessories - Product Code HQB
Causa
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Acción
Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
Acción
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
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.
Medtronic neuromodulation is providing healthcare providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they synchromed infusion pump. an electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und.
Acción
Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. The Medtronic Rep would complete a Physician Notification Confirmation Form. A copy of the recall notification letter and the completed Confirmation Form is to be left with the physician. Customers with questions were instructed to call 1-800-707-0933.
For questions regarding this recall call 763-526-9738.