BEUDAMED
    FDA Enforcement Class II Terminated

    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.

    Recall: Z-0469-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0469-2016
    Event ID
    72748
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instratek, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 30, 2015
    Initiation Date
    November 24, 2015
    Classification Date
    December 22, 2015
    Termination Date
    June 27, 2016
    Address
    15200 Middlebrook Dr Ste G, N/A, Houston, TX, 77058-1217, United States

    Description

    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.

    Reason

    The sterile blade will not fit into the handle provided with the ETTD system.

    Code Info

    Lot number MDHZ620

    Distribution

    US distribution to the states: TX, UT, NY and CO.

    Quantity

    39 units