BEUDAMED
    FDA Recall 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 · Initiated March 10, 2015

    Recall

    Recall Number
    Z-1453-2015
    Event Number
    70872
    Firm
    US Endoscopy Group Inc
    FEI Number
    1000122656
    Product Code
    OCZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 10, 2015
    Posted
    April 16, 2015
    Terminated
    October 27, 2016
    Address
    5976 Heisley Rd, Mentor, OH, 44060-1873

    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..

    Action

    On 03/25/2015 the firm sent recall notification letters to their customers via email.

    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