Recalls / —
—#67984
Product
Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.
- FDA product code
- HWT — Template
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Number-212910.
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 #67984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.