Recall Z-0874-2009 ยท HTZ Instrument, Cutting, Orthopedic
Biomet, Inc.
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
| Date | Jan 13, 2009 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 444 of all products |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.