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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee Posterior Stabilized, Gender Sol

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  Class 2 Device Recall Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee Posterior Stabilized, Gender Sol see related information
Date Initiated by Firm November 13, 2009
Date Posted December 14, 2009
Recall Status1 Terminated 3 on October 15, 2010
Recall Number Z-0501-2010
Recall Event ID 53860
510(K)Number K060370  
Product Classification knee prosthesis implant - Product Code JWH
Product Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.
Code Information Lot 61042477.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
FDA Determined
Cause 2		 Packaging process control
Action Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.
Quantity in Commerce 22
Distribution Nationwide, Korea and Switzerland.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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