Events

Recall of Device Recall MENTOR MemoryGel Sizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mentor Texas, LP..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70042
  • Event Risk Class
    Class 2
  • Event Number
    Z-0964-2015
  • Event Initiated Date
    2014-12-11
  • Event Date Posted
    2015-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132179
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Sizer, mammary, breast implant volume - Product Code MRD
  • 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.

Device

Device Recall MENTOR MemoryGel Sizer
  • Model / Serial
    6790747-030, 6684051-002, 6685063-013, 6728126-044, 6822437-031, 6685063-011, 6728128-035, 6702298-031, 6838011-018, 6733863-003, 6733863-017, 6701421-023, 6696938-022, 6824389-004, 6719893-016, 6687714-031, 6834854-016, 6839585-001, 6849927-019, 6675404-028, 6684051-031, 6803156-029, 6838011-020, 6825406-014, 6751554-012, 6741590-026, 6830995-006, 6721250-014, 6694754-031, 6707932-006, 6789276-002, 6790619-029, 6821980-010, 6853040-025, 6691833-020, 6715539-004, 6836766-012, 6683549-030, 6703183-005, 6789532-021, 6789191-001, 6848592-012, 6790747-028, 6833028-030, 6723961-006, 6716622-011, 6742458-008, 6684051-026, 6685067-008, 6703784-036, 6748082-029, 6748820-019, 6822436-028, 6827017-004, 6829287-016, 6834856-021, 6825200-001, 6701421-034, 6716223-011, 6794993-017, 6723958-007, 6723958-011, 6723957-042.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • 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
  • Product Description
    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
  • Manufacturer
    Mentor Texas, LP.

Manufacturer

Mentor Texas, LP.
  • Manufacturer Address
    Mentor Texas, LP., 3041 Skyway Cir N, Irving TX 75038-3500
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA