BEUDAMED
    FDA Recall Terminated

    CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050

    Recall: Z-1031-2019 · Initiated July 5, 2018

    Recall

    Recall Number
    Z-1031-2019
    Event Number
    82201
    Firm
    CTL Medical Corporation
    FEI Number
    3009051471
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 5, 2018
    Posted
    March 20, 2019
    Terminated
    April 28, 2021
    Address
    4550 Excel Pkwy, Ste 300, Addison, TX, 75001-5714

    Description

    CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050

    Reason

    the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.

    Action

    The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft.

    Distribution

    distributor and user level

    Quantity

    133 total devices