BEUDAMED
    FDA Recall Terminated

    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; 6260-3-214 KINKED T3 DIST STM 14MMX265MM; 6260-3-215 KINKED T3 DIST STM 15MMX265MM; 6260-3-216 KINKED T3 DIST STM 16MMX265MM; 6260-3-217 KINKED T3 DIST STM 17MMX265MM; 6260-3-218 KINKED T3 DIST STM 18MMX265MM; 6260-3-219 KINKED T3 DIST STM 19MMX265MM; 6260-3-220 KINKED T3 DIST STM 20MMX265MM; 6260-3-222 KINKED T3 DIST STM 22MMX265MM; 6260-3-224 KINKED T3 DIST STM 24MMX265MM; 6260-3-314 KINKED T3 DIST STM 14MMX305MM; 6260-3-315 KINKED T3 DIST STM 15MMX305MM; 6260-3-316 KINKED T3 DIST STM 16MMX305MM; 6260-3-317 KINKED T3 DIST STM 17MMX305MM; 6260-3-318 KINKED T3 DIST STM 18MMX305MM; 6260-3-319 KINKED T3 DIST STM 19MMX305MM; 6260-3-320 KINKED T3 DIST STM 20MMX305MM; 6260-3-322 KINKED T3 DIST STM 22MMX305MM; 6260-3-324 KINKED T3 DIST STM 24MMX305MM; LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.

    Recall: Z-0571-04 · Initiated December 30, 2003

    Recall

    Recall Number
    Z-0571-04
    Event Number
    28052
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 30, 2003
    Posted
    July 20, 2004
    Terminated
    February 7, 2006
    Address
    300 Commerce Ct, Mahwah, NJ, 07430-2104

    Description

    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; 6260-3-214 KINKED T3 DIST STM 14MMX265MM; 6260-3-215 KINKED T3 DIST STM 15MMX265MM; 6260-3-216 KINKED T3 DIST STM 16MMX265MM; 6260-3-217 KINKED T3 DIST STM 17MMX265MM; 6260-3-218 KINKED T3 DIST STM 18MMX265MM; 6260-3-219 KINKED T3 DIST STM 19MMX265MM; 6260-3-220 KINKED T3 DIST STM 20MMX265MM; 6260-3-222 KINKED T3 DIST STM 22MMX265MM; 6260-3-224 KINKED T3 DIST STM 24MMX265MM; 6260-3-314 KINKED T3 DIST STM 14MMX305MM; 6260-3-315 KINKED T3 DIST STM 15MMX305MM; 6260-3-316 KINKED T3 DIST STM 16MMX305MM; 6260-3-317 KINKED T3 DIST STM 17MMX305MM; 6260-3-318 KINKED T3 DIST STM 18MMX305MM; 6260-3-319 KINKED T3 DIST STM 19MMX305MM; 6260-3-320 KINKED T3 DIST STM 20MMX305MM; 6260-3-322 KINKED T3 DIST STM 22MMX305MM; 6260-3-324 KINKED T3 DIST STM 24MMX305MM; LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.

    Reason

    Restoration T3 Revision Hip System distal stem has demonstrated fractures.

    Action

    Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.

    Distribution

    The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3.

    Quantity

    8986