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

• Date Initiated by Firm: November 13, 2009
• Date Posted: December 14, 2009
• Recall Status: Terminated 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: 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