—#65560

Product

Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K934765
Affected lot / code info: Lot Number: 26208600; exp. 2013-02.

Why it was recalled

Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.

Timeline

Recall initiated: 2007-10-19
Posted by FDA: 2008-03-19
Terminated: 2008-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.