—#25702

Product

Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 15, standard body. Cat. No. 7841-15-10.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K922071
Affected lot / code info: All lots.

Why it was recalled

The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.

Recalling firm

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

Distribution

Distribution pattern: United States, Australia and Canada.

Timeline

Recall initiated: 2003-01-07
Posted by FDA: 2003-01-28
Terminated: 2004-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.