Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN
This recall has been terminated (originally issued December 22, 2007).
- Company
- Biomet, Inc.
- Recall Initiated
- September 21, 2007
- Posted
- December 22, 2007
- Terminated
- June 30, 2009
- Recall Number
- Z-0318-2008
- Quantity
- 6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide: USA, Canada and Japan.
Lot / Code Info
All units.. including lots 105300, 007602, 011900, 014300, 014900, 103500, 209700, 219100, 232000, 306900, 331600, 520800, 526200, 610000, 619600, 644100, 007600, 007601, 007603, 007604, 011900, 014300, 014900, 014901, 020700, 024100, 103500, 105300, 109004, 123100, 206100, 209700, 219100, 228600, 229200, 232000, 306900, 307000, 317200, 322800, 331600, 403800, 406800, 411200, 411300, 413100, 415000, 418200, 421100, 423900, 429200, 432300, 437300, 443200, 503700, 506800, 511200, 520800, 526200, 545200, 552000, 555700, 555870, 600200, 606900, 610000, 610600, 624140, 626500, 630800, 644100, 645700, 645800, 708600, 708700 and 999999.
Root Cause
Device Design
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.