BEUDAMED
    FDA Recall Terminated

    ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

    Recall: Z-1909-2012 · Initiated May 16, 2012

    Recall

    Recall Number
    Z-1909-2012
    Event Number
    61749
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 16, 2012
    Posted
    June 29, 2012
    Terminated
    March 5, 2013
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

    Reason

    DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U

    Action

    DePuy sent an "URGENT RECALL INFORMATION-FIELD SAFETY NOTICE" letter dated May 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 574-372-7333 for questions regarding this notice.

    Distribution

    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

    Quantity

    431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots