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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 Recall
Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee Posterior Stabilized, Gender Sol
see related information
Date Posted December 14, 2009
Recall Status1 Terminated on October 15, 2010
Recall Number Z-0501-2010
Recall Event ID 53860
Premarket Notification
510(K) Number
K060370 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - 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, Indiana 46580-2746
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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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