FDA Device

Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485150. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.

Hazard

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.

What You Should Do

Remedy

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.

Products

Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485150. A manual surgical instrument for general use; a non-powered, hand-held,
Brand
Biomet, Inc.
UPC
Lots 083700 and 132202.

Units Affected

444 of all products