Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN
FDA device recall Z-0318-2008 · posted 2007-12-22 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008
- Distribution
- Worldwide: USA, Canada and Japan.
- Date initiated
- 2007-09-21
- Date posted
- 2007-12-22
- Date terminated
- 2009-06-30
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.