Recalls / —
—#76189
Product
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 75 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485157. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
- FDA product code
- HTZ — Instrument, Cutting, Orthopedic
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lots 084520 and 132902.
Why it was recalled
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 (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582
Distribution
- Distribution pattern
- Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
Timeline
- Recall initiated
- 2008-12-18
- Posted by FDA
- 2009-01-13
- Terminated
- 2010-01-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #76189. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.