Recalls / —

—#76192

Product

Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 72.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485159. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.

FDA product code

HTZ — Instrument, Cutting, Orthopedic

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot 084801.

Why it was recalled

Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter entitled "URGENT MEDICAL DEVICE REMOVAL NOTICE" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern

Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.

Timeline

Recall initiated

2008-12-18

Posted by FDA

2009-01-13

Terminated

2010-01-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #76192. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.