BEUDAMED
    FDA Enforcement Class II Terminated

    DISP 9730950 STRL SPHERE, 1 PK INSERT

    Recall: Z-1581-2014 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-1581-2014
    Event ID
    68145
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2014
    Initiation Date
    April 24, 2014
    Classification Date
    November 20, 2014
    Termination Date
    December 29, 2014
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    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.

    Code Info

    Lot No.: B135276281

    Distribution

    Nationwide Distribution

    Quantity

    26,674 total