FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485156. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
- Recall number
- Z-0879-2009
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485156. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
- Status
- Terminated
- Initiated
- 2008-12-18
- Posted
- 2009-01-13
- Terminated
- 2010-01-20
- 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.
- Lot, serial or model codes
- Lots 084400 and 132802.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTZ
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28