—#87610

Product

Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K941941
Affected lot / code info: Lots 918790, 918800 and 110700.

Why it was recalled

The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained.

Root cause (FDA determination)

Employee error

Action the firm took

Hospitals, distributors, and other customers were notified by letter dated 12/22/09 and instructed to locate and return these lots of product. Questions related to this notice should be directed to the firm at 800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.

Recalling firm

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

Distribution

Distribution pattern: Arkansas, California, Delaware, Florida, Kansas, Kentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, Chile, Germany, Italy, Japan and Norway.

Timeline

Recall initiated: 2009-12-22
Posted by FDA: 2010-02-02
Terminated: 2010-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87610. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.