—#47847

Product

Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-14-04 (00786101404).

FDA product code: LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K961378
Affected lot / code info: Lots 60454196, 60454197, 60454198, 60454199, 60465016 and 60465017.

Why it was recalled

Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Timeline

Recall initiated: 2006-08-02
Posted by FDA: 2006-08-31
Terminated: 2007-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47847. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.