Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.
FDA Recall Z-0646-2010 · Posted 2010-01-15
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2009-12-01
Date Terminated2010-10-18
Product Quantity92
Reason for Recall
The locking hook tabs may fracture and fragments remain in the patient post-operatively.
Firm Action
Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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