BEUDAMED
    FDA Recall Terminated

    AxiEM EM Knee Kit, and associated workstation.

    Recall: Z-0718-06 · Initiated February 1, 2006

    Recall

    Recall Number
    Z-0718-06
    Event Number
    34604
    Firm
    Medtronic Navigation, Inc
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 1, 2006
    Posted
    April 7, 2006
    Terminated
    April 6, 2006
    Address
    826 Coal Creek Circle, Louisville, CO, 80027-9710

    Description

    AxiEM EM Knee Kit, and associated workstation.

    Reason

    Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

    Action

    Medtronic field personnel were notified by letter on 02/01/2006 and instructed to immediately contact each affected site and schedule an upgrade with the revised firmware

    Distribution

    AZ, CA, CO, GA, IL, LA, MT, NE, NV, OH, TX. No military or government distribution. Foreign distribution to Australia, Austria, Israel, Singapore, Switzerland, UK.

    Quantity

    84 kits