—#64477

Product

Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected 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.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Worldwide: USA, Canada and Japan.

Timeline

Recall initiated: 2007-09-21
Posted by FDA: 2007-12-22
Terminated: 2009-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.