—#72517

Product

Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.

FDA product code: GFA — Blade, Saw, General & Plastic Surgery, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lots 010180, 865890, 439380, 850170 and 918020.

Why it was recalled

The blades will oxidize after the first cleaning.

Root cause (FDA determination)

Process control

Action the firm took

Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and China.

Timeline

Recall initiated: 2008-07-18
Posted by FDA: 2008-09-29
Terminated: 2009-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.