—#73487

Product

Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.

FDA product code: JDC — Prosthesis, Elbow, Constrained, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013042
Affected lot / code info: Lot 440370.

Why it was recalled

The component in the package is not the correct size.

Root cause (FDA determination)

Packaging process control

Action the firm took

Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.

Timeline

Recall initiated: 2008-05-23
Posted by FDA: 2008-10-03
Terminated: 2009-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73487. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.