Events

Recall of Device Recall Mentor

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

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
    29132
  • Event Risk Class
    Class 3
  • Event Number
    Z-0977-04
  • Event Initiated Date
    2003-12-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33184
  • 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
    Plastic Surgery And Accessories Kit - Product Code FTN
  • Reason
    Device was distributed without the dome part accessory, part number 350-dompk.
  • Action
    The recall letters for Lot 269402 were sent on 12/16/2003. The recall letters for Lot 264358 were sent on 02/06/2004. Each letter included 5 dome pack accessories as a temporary corrective action.

Device

Device Recall Mentor
  • Model / Serial
    Lot numbers 269402 and 264358
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. Recalled product was shipped domestically to accounts in AZ, AR, CA, GA, IL, IN, KY, MD, MI, OH, OK, OR, TX, and NY. There was no foreign distribution.
  • Product Description
    Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
  • Manufacturer
    Mentor Texas, Inc

Manufacturer

Mentor Texas, Inc
  • Manufacturer Address
    Mentor Texas, Inc, 3041 Skyway Cir N, Irving TX 75038-3500
  • Source
    USFDA