BEUDAMED
    FDA Enforcement Class II Terminated

    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

    Recall: Z-2780-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2780-2016
    Event ID
    74899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mentor Texas, LP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    August 9, 2016
    Classification Date
    September 9, 2016
    Termination Date
    March 8, 2017
    Address
    3025 Skyway Cir N, N/A, Irving, TX, 75038-3524, United States

    Description

    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

    Reason

    The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

    Code Info

    Lot 6944785

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

    Quantity

    48 units