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.
FDA Recall Z-1262-2009 · Posted 2009-05-12
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHTQ
Date Initiated2009-03-13
Date Terminated2009-12-22
Product Quantity37
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.
Firm 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.
Root Cause
Finished device change control
Distribution Pattern
Worldwide Distribution -- US, Australia, and Germany.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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