BEUDAMED
    FDA Enforcement Class II Terminated

    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

    Recall: Z-2591-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2591-2014
    Event ID
    69022
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mentor Texas, LP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    July 2, 2014
    Classification Date
    September 4, 2014
    Termination Date
    April 6, 2015
    Address
    3041 Skyway Cir N, Irving, TX, 75038-3500, United States

    Description

    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

    Reason

    The device labeling is stamped with 330cc and the device is actually 380cc device.

    Code Info

    Part Number (PN) 351-3380SZ Lot Number 6830722

    Distribution

    U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.

    Quantity

    34 units