BEUDAMED
    FDA Enforcement Class II Terminated

    CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

    Recall: Z-1030-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1030-2019
    Event ID
    82201
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CTL Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 27, 2019
    Initiation Date
    July 5, 2018
    Classification Date
    March 20, 2019
    Termination Date
    April 28, 2021
    Address
    4550 Excel Pkwy Ste 300, N/A, Addison, TX, 75001-5714, United States

    Description

    CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

    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.

    Code Info

    Lot 7EQAB-D, 7ATAB-D

    Distribution

    distributor and user level

    Quantity

    133 total devices