BEUDAMED
    FDA Recall Terminated

    Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

    Recall: Z-0114-2014 · Initiated August 13, 2013

    Recall

    Recall Number
    Z-0114-2014
    Event Number
    65997
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    JDQ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 13, 2013
    Posted
    October 30, 2013
    Terminated
    August 18, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

    Reason

    When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.

    Action

    Synthes sent a Urgent Medical Device Notification dated August 13, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken: This notification is to make you aware of the issue and the importance of completely releasing the tensioning trigger before cutting the implant. Please take the following action: "To ensure your receipt and understanding of this information, Please complete the verification section of this letter and return to Synthes by either of the following methods: " Fax: 1-888-352-9616 or " Scan/email: [email protected] If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant.

    Distribution

    Worldwide Distribution - US (nationwide) and country of Mexico.

    Quantity

    319