—#25487

Product

Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.5 neck length on Co-Cr tapers. Cat. No. 6418-28-03

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: all lots.

Why it was recalled

Compression test results are not in accordance with device approval submission

Root cause (FDA determination)

Other

Action the firm took

Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.

Recalling firm

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

Distribution

Distribution pattern: United States.

Timeline

Recall initiated: 2003-01-06
Posted by FDA: 2003-01-23
Terminated: 2003-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25487. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.