| Class 2 Device Recall NexGen Complete Knee Solution | |
Date Initiated by Firm | June 07, 2013 |
Date Posted | August 22, 2013 |
Recall Status1 |
Terminated 3 on December 15, 2014 |
Recall Number | Z-2028-2013 |
Recall Event ID |
65413 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile;
00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile;
00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile;
00595204117 Articular Surface XLPE CR ART SURF 5-6/STRGRN 17, Rx, Sterile;
00595204120 Articular Surface XLPE CR ART SURF 5-6/STRGRN 20, 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 IN 46580-2746
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For Additional Information Contact | Jaime Weeks 800-613-6131 |
Manufacturer Reason for Recall | 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 |
FDA Determined Cause 2 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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