BEUDAMED
    FDA Recall 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 · Initiated September 18, 2012

    Recall

    Recall Number
    Z-0922-2013
    Event Number
    63551
    Firm
    Instratek, Incorporated
    FEI Number
    1000118334
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 18, 2012
    Posted
    March 8, 2013
    Terminated
    April 10, 2013
    Address
    4141 Directors Row, Ste. H, Houston, TX, 77092-8743

    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.

    Action

    The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.

    Distribution

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

    Quantity

    235