Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 75 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-
FDA device recall Z-0880-2009 · posted 2009-01-13 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HTZ
- Quantity affected
- 444 of all products
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
- Date initiated
- 2008-12-18
- Date posted
- 2009-01-13
- Date terminated
- 2010-01-20
- Location
- Warsaw, IN
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