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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach

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  Class 2 Device Recall Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach see related information
Date Initiated by Firm March 13, 2009
Date Posted May 12, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-1262-2009
Recall Event ID 51320
Product Classification Orthopedic manual surgical instrument - Product Code HTQ
Product Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07.

A reusable cutting instrument that is used in total knee arthroplasty surgery.
Code Information Lot Number 61075338.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6181
Manufacturer Reason
for Recall		 The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.
FDA Determined
Cause 2		 Finished device change control
Action Distributors were notified by an "Urgent: Device Recall" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities. Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131.
Quantity in Commerce 37
Distribution Worldwide Distribution -- US, Australia, and Germany.
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.
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