BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

    Recall: Z-2475-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2475-2015
    Event ID
    71834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    July 22, 2015
    Classification Date
    August 27, 2015
    Termination Date
    August 18, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

    Reason

    The end cap may loosen and detach making the instrument non-functional. No injuries reported.

    Code Info

    Part Number: 03.501.080 Lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078 8130898 8130975 8145793 8159386 8166417 8186954 8207769 8209190 8215969 8215999 8241958 8290959 8290968

    Distribution

    Nationwide and internationally to Canada.

    Quantity

    451