BEUDAMED
    FDA Recall 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-0276-2016 · Initiated October 19, 2015

    Recall

    Recall Number
    Z-0276-2016
    Event Number
    72469
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    JDQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 19, 2015
    Posted
    November 14, 2015
    Terminated
    August 26, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    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

    Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.

    Action

    Communication to the accounts having record of receiving this product was sent on October 19, 2015.

    Distribution

    Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.

    Quantity

    267