Events

Recall of Device Recall SalineFilled SPECTRUM Breast Implants

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
    76868
  • Event Risk Class
    Class 2
  • Event Number
    Z-2070-2017
  • Event Initiated Date
    2017-03-27
  • Event Date Posted
    2017-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154428
  • 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
    Prosthesis, breast, inflatable, internal, saline - Product Code FWM
  • Reason
    Missing dome pack accessory.
  • Action
    Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) . Actions Requested If you have already implanted a device from this lot, there is no risk to patient health and you do not need to take any action. Immediately identify all unused units and return them to Mentor per the normal return process.Forward this notice to anyone in your facility that needs to be informed. If you have sent these units to another facility, forward this notice to that facility. Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned. We apologize for any inconvenience this may cause. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter. Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. 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. For further questions please call (972) 252-6060. Thank you for your attention and cooperation.

Device

Device Recall SalineFilled SPECTRUM Breast Implants
  • Model / Serial
    Lot Number: 7377332
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
  • Product Description
    Mentor Smooth Round SPECTRUM Post- || Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
  • 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