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.
Recall
- Recall Number
- Z-1262-2009
- Event Number
- 51320
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- HTQ
- Status
- Terminated
- Root Cause
- Finished device change control
- Initiated
- March 13, 2009
- Posted
- May 12, 2009
- Terminated
- December 22, 2009
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
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.
The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.
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.
Worldwide Distribution -- US, Australia, and Germany.
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