Recall Z-1361-2008 ยท HWT Template
Biomet, Inc.
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.
| Date | Mar 28, 2008 (initiated Feb 12, 2008) |
| Status | Terminated |
| Reason | The instrument's sizing line is in the wrong place. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 35 (31 to U.S. and 4 international). |
| Distribution | Worldwide: USA, Canada, China and Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.