BEUDAMED
    FDA Recall Open, Classified

    Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

    Recall: Z-2269-2020 · Initiated August 21, 2018

    Recall

    Recall Number
    Z-2269-2020
    Event Number
    85407
    Firm
    Genicon, Inc.
    FEI Number
    3002590791
    Product Code
    GEA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 21, 2018
    Address
    6869 Stapoint Ct, Ste 112, Winter Park, FL, 32792-6603

    Description

    Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - 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.

    Action

    A customer letter will be issued to impacted customers during the week of 5/25/2020. Customers are asked to inspect their inventory for impacted lots and return the devices to Genicon. Customers may contact Mr. Justin Colon, Genicon Customer Service on Mon-Thurs 9am-4pmEST at 407-657-4851, extension #800.

    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

    2 boxes (5 units per box)