BEUDAMED
    FDA Recall Terminated

    VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

    Recall: Z-1941-2020 · Initiated March 26, 2020

    Recall

    Recall Number
    Z-1941-2020
    Event Number
    85414
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 26, 2020
    Terminated
    March 26, 2021
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

    Reason

    Nonconforming product; length of the product measured shorter than the labeled length.

    Action

    Medtronic, Inc., notified customers on March 31, 2020 via " Urgent Voluntary Market Removal (Recall) Vertex Select Multi Axial Screw (MAS) Product Code 6958838 Lot H5517628. The recall letter identified the affected product and requested the customers to remove the impacted product from normal storage location and complete the return form.

    Distribution

    US Nationwide distribution in the states of CA and MI.

    Quantity

    83 units.