BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2326-2016 · Initiated July 1, 2016

    Recall

    Recall Number
    Z-2326-2016
    Event Number
    74565
    FEI Number
    1000118360
    Product Code
    FTR
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 1, 2016
    Terminated
    December 9, 2016
    Address
    3025 Skyway Cir N, Mentor Texas, LP., Irving, TX, 75038-3524

    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.

    Action

    The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit.

    Distribution

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

    Quantity

    35 units