BEUDAMED
    FDA Recall Terminated

    Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581

    Recall: Z-0435-2008 · Initiated October 30, 2007

    Recall

    Recall Number
    Z-0435-2008
    Event Number
    45478
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 30, 2007
    Posted
    January 24, 2008
    Terminated
    April 21, 2008
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581

    Reason

    Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.

    Action

    Consignees were notified via Urgent Information, Recall Notice(letter) dated 10/30/07 to determine whether they have product on hand and to contact their sales representative to return the product. Dear Doctor letters will be issued to implanting physicians as they are identified.

    Distribution

    Nationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia.

    Quantity

    4