BEUDAMED
    FDA Recall Terminated

    DISP 9730950 STRL SPHERE, 1 PK INSERT

    Recall: Z-1581-2014 · Initiated April 24, 2014

    Recall

    Recall Number
    Z-1581-2014
    Event Number
    68145
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 24, 2014
    Posted
    May 9, 2014
    Terminated
    December 29, 2014
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    DISP 9730950 STRL SPHERE, 1 PK INSERT

    Reason

    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

    Action

    Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.

    Distribution

    Nationwide Distribution

    Quantity

    26,674 total