BEUDAMED
    FDA Enforcement Class II Ongoing

    Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

    Recall: Z-2268-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2268-2020
    Event ID
    85407
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Genicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2020
    Initiation Date
    August 21, 2018
    Classification Date
    June 5, 2020
    Address
    6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, 32792-6603, United States

    Description

    Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

    Reason

    There is potential for the plastic optical tip to become detached from the metal shaft.

    Code Info

    Lots I7779-C and I8144-C

    Distribution

    US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand

    Quantity

    42 boxes (5 units per box)