BEUDAMED
    FDA Recall 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 · Initiated July 2, 2014

    Recall

    Recall Number
    Z-2591-2014
    Event Number
    69022
    FEI Number
    1000118360
    Product Code
    MRD
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 2, 2014
    Posted
    September 4, 2014
    Terminated
    April 6, 2015
    Address
    3041 Skyway Cir N, Mentor Texas, LP., Irving, TX, 75038-3500

    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.

    Action

    Mentor sent an Important Customer Notification letter dated July 17, 2014 to all affected customers and follow-up with a visit by the local sales representative. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify all unsused product from lot list provided and maintain a copy of this notice with the affected product. For question contact your local Sales Representative or Mentor Customer Service at 1-800-235-5731.

    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