BEUDAMED
    FDA Recall Terminated

    Guardian Distal Femur Axial Pin

    Recall: Z-0523-06 · Initiated January 3, 2006

    Recall

    Recall Number
    Z-0523-06
    Event Number
    34526
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 3, 2006
    Posted
    February 16, 2006
    Terminated
    January 29, 2007
    Address
    5677 Airline Road P.O. Box 100, Arlington, TN, 38002-0100

    Description

    Guardian Distal Femur Axial Pin

    Reason

    The product was not fully assembled prior to packaging.

    Action

    The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.

    Distribution

    Nationwide and PR

    Quantity

    10