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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Complete Knee Solution

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 Class 2 Recall
NexGen Complete Knee Solution
see related information
Date Posted August 22, 2013
Recall Status1 Open
Recall Number Z-2000-2013
Recall Event ID 65413
Premarket Notification
510(K) Numbers
K003910  K892800  K933785  K951185 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Information all codes
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Jaime Weeks
800-613-6131
Manufacturer Reason
for Recall
Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Alth
FDA Determined
Cause 2
DESIGN: Labeling Design
Action 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.
Quantity in Commerce 192,355 all devices
Distribution Worldwide Distribution-USA (nationwide) and the country of Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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