BEUDAMED
    FDA Enforcement Class II Ongoing

    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

    Recall: Z-1309-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1309-2022
    Event ID
    90400
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Skytron, Div. The KMW Group, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    June 2, 2022
    Classification Date
    June 30, 2022
    Address
    5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515, United States

    Description

    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

    Reason

    Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.

    Code Info

    Lot Code: All units of model H8-300-40-A are affected. Code Info: GCX mounting bracket does not have UDI. Ergon 3 booms after September 2016 have UDI. DI of units manufactured after September 2016 is 10841736100889. Units manufactured prior to September 2016 do not have UDI.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada and Japan.

    Quantity

    731