BEUDAMED
    FDA Enforcement Class II Ongoing

    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

    Recall: Z-0310-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0310-2021
    Event ID
    86412
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Genicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 11, 2020
    Initiation Date
    September 17, 2020
    Classification Date
    October 30, 2020
    Address
    6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, 32792-6603, United States

    Description

    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

    Reason

    Device malfunction causing the applier to jam, and clip loading failures.

    Code Info

    Model # 360-010-001 (A Li-Gator) lot codes: I8250 I8251 I8252 I8820 I8821 I8822 I8823 I8824 I8825 I9571-A I9572-A I9573-A I9716-A I9717-A I9718-A I9719-A J0113-A J0114-A J0115-A J0225-A J0227-A J0228-A J0229-A J0230-A J0231-A J0240-A J0243-A J0287-A

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of FL, TN, MO, CA, GA, and IN. The countries of Chile, Croatia, Dubai (UAE), Equador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Iraq, Ireland, Israel, Jordan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Palestinian, Quatar, Saudi Arabia, Slovenia, South Africa, Switzerland, Tunisia, United Kingdom, and Venezuela.

    Quantity

    8,872 devices