Events

Recall of Tissue expander

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
    74895
  • Event Risk Class
    Class 2
  • Event Number
    Z-2748-2016
  • Event Initiated Date
    2016-08-09
  • Event Date Posted
    2016-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148701
  • 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
    Expander, skin, inflatable - Product Code LCJ
  • Reason
    Tissue expander product mix found: cpx4 350cc was placed in a carton for the cpx4 450cc.
  • Action
    The firm, Mentor, sent an "MEDICAL DEVICE REMOVAL" letter dated 8/11/2016 to affected consignees. The letter will be followed up with a respective sales representative visit. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately identify all unused units and return them per the normal return process; forward the letter to anyone your facility that needs to be informed; if you have sent these units to another facility, forward the letter to that facility; and maintain awareness of the letter until all units in your inventory have been returned. If you have any questions, please contact your local Mentor sales representative or Mentor Customer Service at 1-800-235-5731.

Device

Tissue expander
  • Model / Serial
    Lot 6981543
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
  • Product Description
    MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 || The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
  • Manufacturer
    Mentor Texas, LP.

Manufacturer

Mentor Texas, LP.
  • Manufacturer Address
    Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA