BEUDAMED
    FDA Enforcement Class II Terminated

    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

    Recall: Z-2326-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2326-2016
    Event ID
    74565
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mentor Texas, LP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    July 1, 2016
    Classification Date
    August 3, 2016
    Termination Date
    December 9, 2016
    Address
    3025 Skyway Cir N, Irving, TX, 75038-3524, United States

    Description

    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

    Reason

    The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

    Code Info

    7316994

    Distribution

    Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.

    Quantity

    35 units