Recalls / —

—#42920

Product

Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.

FDA product code

GFG — Bit, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lots 044250, 134170, 781690, 781700, 838920, 914620 and 914630.

Why it was recalled

The bit may bend or fracture during use.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified to return the product via letter dated 11/10/05.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern

Nationwide, Australia, Belgium, Columbia, Finland, Israel, Poland and United Kingdom.

Timeline

Recall initiated

2005-11-10

Posted by FDA

2005-12-28

Terminated

2006-01-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.