—#79881

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.

FDA product code: HTQ — Broach
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Number 61075338.

Why it was recalled

The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.

Root cause (FDA determination)

Finished device change control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution -- US, Australia, and Germany.

Timeline

Recall initiated: 2009-03-13
Posted by FDA: 2009-05-12
Terminated: 2009-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #79881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.