BEUDAMED
    FDA Enforcement Class II Terminated

    Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.

    Recall: Z-0922-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0922-2013
    Event ID
    63551
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instratek, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    September 18, 2012
    Classification Date
    March 8, 2013
    Termination Date
    April 10, 2013
    Address
    4141 Directors Row, Ste. H, Houston, TX, 77092-8743, United States

    Description

    Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.

    Reason

    Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.

    Code Info

    Model number 1052; Lots M674180, MAKL170, M674200

    Distribution

    USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.

    Quantity

    235