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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Optigun

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 Class 2 Recall
Biomet Optigun
see related information
Date Posted December 22, 2007
Recall Status1 Terminated on June 30, 2009
Recall Number Z-0318-2008
Recall Event ID 44892
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN
Code Information 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.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46581-0587
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
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 in Commerce 6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008
Distribution Worldwide: USA, Canada and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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