Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485152. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
FDA Recall Z-0875-2009 · Posted 2009-01-13
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHTZ
Date Initiated2008-12-18
Date Terminated2010-01-20
Product Quantity444 of all products
Reason for Recall
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Firm Action
Consignees were notified by letter entitled "URGENT MEDICAL DEVICE REMOVAL NOTICE" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.
Root Cause
Other
Distribution Pattern
Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.