BEUDAMED
    FDA Recall Terminated

    Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

    Recall: Z-1750-2018 · Initiated March 23, 2018

    Recall

    Recall Number
    Z-1750-2018
    Event Number
    79792
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 23, 2018
    Terminated
    July 25, 2021
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

    Reason

    Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

    Action

    The firm initiated their recall by letter on 03/23/2018. The recall notice requested: "1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. "

    Distribution

    Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France

    Quantity

    39 units