Recall Z-0318-2008 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN
| Date | Dec 22, 2007 (initiated Sep 21, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.