BEUDAMED
    FDA Recall Terminated

    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

    Recall: Z-0964-2015 · Initiated December 11, 2014

    Recall

    Recall Number
    Z-0964-2015
    Event Number
    70042
    FEI Number
    1000118360
    Product Code
    MRD
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 11, 2014
    Posted
    January 13, 2015
    Terminated
    January 4, 2016
    Address
    3041 Skyway Cir N, Mentor Texas, LP., Irving, TX, 75038-3500

    Description

    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

    Reason

    The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

    Action

    Mentor sent an Important Labeling Correction letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to follow-up with sales representative visits. The recall letter notifies the customer of the issue, but does not instruct them to return the product. Should the customer chose to return the product, all returned product will be tagged to denote no further distribution. The recalled units under firm control have been placed on hold in the inventory system. If you have any questions related to this notice, please contact your local Mentor Sales Representative, or Mentor Customer Service at 1-800-235-5731.

    Distribution

    US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA

    Quantity

    45 units