—#64410

Product

Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot 522080.

Why it was recalled

Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.

Root cause (FDA determination)

Process control

Action the firm took

The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2007-08-09
Posted by FDA: 2007-10-27
Terminated: 2009-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64410. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.