BEUDAMED
    FDA Enforcement Class II Terminated

    Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

    Recall: Z-1664-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1664-2015
    Event ID
    71256
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    United Surgical Associates
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 3, 2015
    Initiation Date
    April 13, 2015
    Classification Date
    May 23, 2015
    Termination Date
    July 14, 2015
    Address
    2235 Pennsylvania St, Fort Wayne, IN, 46803-2138, United States

    Description

    Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

    Reason

    The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

    Code Info

    Product #: i-94103 Elastic Ankle Support SM Lot#: AP20140815001 Product #: i-94105 Elastic Ankle Support MD Lot#: AP20140815001 Product #: i-94107 Elastic Ankle Support LG Lot#: AP20140815001

    Distribution

    Domestic: HI International; None

    Quantity

    1278