BEUDAMED
    FDA Enforcement Class I Terminated

    LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

    Recall: Z-1820-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1820-2013
    Event ID
    65591
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2013
    Initiation Date
    July 11, 2013
    Classification Date
    July 31, 2013
    Termination Date
    July 10, 2014
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

    Reason

    The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.

    Code Info

    CATALOG NO. : Part Number: 1987-19-055 and lot numbers:130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1. In certain documentation, these alphanumeric lot numbers may appear with three zeros at the end (e.g. A1TAR1 may appear as A1TAR1000).

    Distribution

    Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.

    Quantity

    58 U.S. / 39 OUS