BEUDAMED
    FDA Enforcement Class II Terminated

    Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.

    Recall: Z-1453-2015 · Reported April 22, 2015

    Enforcement

    Recall Number
    Z-1453-2015
    Event ID
    70872
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    US Endoscopy Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 22, 2015
    Initiation Date
    March 10, 2015
    Classification Date
    April 16, 2015
    Termination Date
    October 27, 2016
    Address
    5976 Heisley Rd, N/A, Mentor, OH, 44060-1873, United States

    Description

    Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.

    Reason

    A wire component on the distal grasping assembly of the device became detached..

    Code Info

    Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.

    Distribution

    Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. Product was also sent to the following countries: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.

    Quantity

    1695 units