—#75730

Product

Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-12. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lots 61007188, 60987590, 60969807, 60976981 and 60976982.

Why it was recalled

Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.

Root cause (FDA determination)

Employee error

Action the firm took

Zimmer sales force and distribution sites were notified of the recall via email on 12/15/08 and instructed to inventory, return the affected products and to provide a copy of the recall letter to those customers to whom they had further distributed the products. The 'Urgent: Device Recall" letter dated 12/12/08, described the problem and the potential risks. For additional information, contact Zimmer, Inc., at 1-800-613-6131.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.

Timeline

Recall initiated: 2008-12-12
Posted by FDA: 2009-01-23
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75730. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.