Date Initiated by Firm | October 12, 2006 |
Date Posted | November 22, 2006 |
Recall Status1 |
Terminated 3 on December 10, 2007 |
Recall Number | Z-0209-2007 |
Recall Event ID |
36599 |
510(K)Number | K963148 |
Product Classification |
knee prosthesis - Product Code JWH
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Product | Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02. |
Code Information |
Lot 60472442; exp. May 2011. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | 800-846-4637 |
Manufacturer Reason for Recall | The polyethylene tibial articular surface may not lock into some of the tibial plates. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified by a letter dated 10/12/06 and sent to operating room supervisors and Zimmer distributors to cease using the product and to return it to the firm. |
Quantity in Commerce | 18 |
Distribution | Nationwide. |
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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510(K) Database | 510(K)s with Product Code = JWH
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