—#49851

Product

NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272522.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot 97000418.

Why it was recalled

The device was cut to an incorrect angle, which may result in an incorrect bone cut.

Root cause (FDA determination)

Other

Action the firm took

Product was removed from customer location during visit on 10/10/2006.

Recalling firm

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

Distribution

Distribution pattern: One medical facility in Michigan.

Timeline

Recall initiated: 2006-10-10
Posted by FDA: 2007-03-28
Terminated: 2007-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49851. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.