BEUDAMED
    FDA Enforcement Class II Terminated

    LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER 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-1918-2012 · Reported July 11, 2012

    Enforcement

    Recall Number
    Z-1918-2012
    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

    LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER 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:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000.

    Distribution

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

    Quantity

    Eighty-five (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots