Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The de
FDA device recall Z-1361-2008 · posted 2008-03-28 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The instrument's sizing line is in the wrong place.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HWT
- Quantity affected
- 35 (31 to U.S. and 4 international).
- Distribution
- Worldwide: USA, Canada, China and Finland.
- Date initiated
- 2008-02-12
- Date posted
- 2008-03-28
- Date terminated
- 2009-06-26
- Location
- Warsaw, IN
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