Events

Safety Alert for Mentor breast implants

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Mentor.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-05-21
  • Event Date Posted
    2013-05-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130521b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: mentor breast implants the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning breast implants manufactured by mentor. the affected sales code and lot number are 3545160 and 5741158 respectively, with expiry date in may 2012. the manufacturer has identified an issue where one lot of these products was inadvertently shipped out beyond its expiration date because of a scanning error in the company’s inventory and distribution system. the affected lot may contain a secondary inventory label with an incorrect expiry date (different from the product label). to date, no complaints have been reported that are connected to this issue. the manufacturer advises users to immediately identify and quarantine all unused product and return them to their supplier for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con273701 if you are in possession of the product, please contact your supplier for necessary actions. posted on 21 may 2013.

Device

Mentor breast implants
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Mentor breast implants
  • Manufacturer
    Mentor

Manufacturer

Mentor