BEUDAMED
    FDA Enforcement Class II Terminated

    Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.

    Recall: Z-1063-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-1063-2014
    Event ID
    67446
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implantech Associates Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    January 29, 2014
    Classification Date
    February 20, 2014
    Termination Date
    March 12, 2015
    Address
    6025 Nicolle St Ste A, Ventura, CA, 93003-7602, United States

    Description

    Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.

    Reason

    Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.

    Code Info

    Catalog Number SLV634, Lot Number 852766.

    Distribution

    Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.

    Quantity

    300