Events

Recall of Device Recall MENTOR Sterile Saline Mammary Volume 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
    69022
  • Event Risk Class
    Class 2
  • Event Number
    Z-2591-2014
  • Event Initiated Date
    2014-07-02
  • Event Date Posted
    2014-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129359
  • 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 device labeling is stamped with 330cc and the device is actually 380cc device.
  • Action
    Mentor sent an Important Customer Notification letter dated July 17, 2014 to all affected customers and follow-up with a visit by the local sales representative. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify all unsused product from lot list provided and maintain a copy of this notice with the affected product. For question contact your local Sales Representative or Mentor Customer Service at 1-800-235-5731.

Device

Device Recall MENTOR Sterile Saline Mammary Volume Sizer
  • Model / Serial
    Part Number (PN) 351-3380SZ Lot Number 6830722
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
  • Product Description
    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer || REF 351-3380SZ 380 cc LOT 6830722. || Product Usage: || This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
  • 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