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 Recall Z-1361-2008 · Posted 2008-03-28
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWT
Date Initiated2008-02-12
Date Terminated2009-06-26
Product Quantity35 (31 to U.S. and 4 international).
Reason for Recall
The instrument's sizing line is in the wrong place.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide: USA, Canada, China and Finland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.