FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN
- Recall number
- Z-0319-2008
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN
- Status
- Terminated
- Initiated
- 2007-09-21
- Posted
- 2007-12-22
- Terminated
- 2009-06-30
- Reason
- Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement.
- Root cause
- Device Design
- Action
- Consignees were notified via Urgent Medical Device Correction letter dated 9/21/07 to assure the screw components are fully seated and secure, to not use any guns with loose or missing screws, and to contact Biomet for instructions to return all instruments for evaluation and refurbishment.
- Quantity
- 6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008
- Distribution
- Worldwide: USA, Canada and Japan.
- Lot, serial or model codes
- All units including lots 429900, 642100 and 647700.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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