—#73485

Product

Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 097525, 097526, 532370 and 532810.

Why it was recalled

The pin and clip may fracture during use.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.

Timeline

Recall initiated: 2008-07-28
Posted by FDA: 2008-10-24
Terminated: 2009-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.