Events

Recall of Artoura Breast 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
    74899
  • Event Risk Class
    Class 2
  • Event Number
    Z-2781-2016
  • Event Initiated Date
    2016-08-09
  • Event Date Posted
    2016-09-10
  • 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=148715
  • 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
    The cpx4 tissue expander may have been packaged in the artoura tissue expander box.
  • Action
    Mentor Texas sent an Urgent Field Safety Notice dated August 11, 2016 to customers.via letter and a follow-up with respective Sales Representative visit. The letter identified the affected product, problems and actions to be taken. Customers were informed the firm will credit/replace returned affected products. For questions contact your Sales Representative .

Device

Artoura Breast Tissue Expander
  • Model / Serial
    Lot 6947019
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
  • Product Description
    CPX4 Breast Tissue Expander 650 cc || : || Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular 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