—#69371

Product

Biomet Vanguard Knee Instrumentation, Part Number: 32-487062, 67.5/70/75mm Sizing Wing, Biomet UK Ltd, Made in Britain; The device is a preparatory instrument used for femoral knee insertion. (Distributed to Puerto Rico).

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Number-1162107

Why it was recalled

The instrument's sizing line is in the wrong place.

Root cause (FDA determination)

Process control

Action the firm took

Distributors were notified via Urgent Medical Device Removal Notice letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. The Puerto Rico consignee was notified by Biomet UK, Ltd. via letter on 2/26/08.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Worldwide: USA, Canada, China and Finland.

Timeline

Recall initiated: 2008-02-12
Posted by FDA: 2008-03-28
Terminated: 2009-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.