BEUDAMED
    FDA Enforcement Class II Terminated

    ULTIMA*LX STM,POL 10/12TAP/SZ3 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-1908-2012 · Reported July 11, 2012

    Enforcement

    Recall Number
    Z-1908-2012
    Event ID
    61749
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2012
    Initiation Date
    May 16, 2012
    Classification Date
    June 29, 2012
    Termination Date
    March 5, 2013
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    ULTIMA*LX STM,POL 10/12TAP/SZ3 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

    Code Info

    Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.

    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