BEUDAMED
    FDA Recall Terminated

    Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

    Recall: Z-0290-2008 · Initiated October 4, 2007

    Recall

    Recall Number
    Z-0290-2008
    Event Number
    45462
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    HWR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 4, 2007
    Posted
    November 27, 2007
    Terminated
    July 22, 2009
    Address
    5677 Airline Road, Arlington, TN, 38002-0100

    Description

    Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

    Reason

    Breakage: breaking of the connecting foot that is on the distal surface of the instrument

    Action

    The firm notified their distributors of the recall on October 4, 2007, with an Urgent Medical Device Recall letter explaining the problem and requesting return of the product from their inventory and from their consignees. The hospitals were notified of the recall on October 4, 2007 using the same Urgent Device Recall Letter.

    Distribution

    Worldwide-USA and Australia

    Quantity

    66 units