Events

Recall of Pre-filled silicone gel templates for breast prostheses

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Perouse Plasty.

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
  • Date
    2014-06-06
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/gabarits-pre-remplis-de-gel-de-silicone-pour-protheses-mammaires-mentor-rappel-de-lots
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    The ANSM has been informed of the implementation of a recall of two sets of templates pre-filled with silicone gel for breast prostheses, the company Mentor, carried out by the company Perouse Plasty. The health professionals concerned received the attached letter (06/06/2014) (520 KB).

Device

Pre-filled silicone gel templates for breast prostheses
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Perouse Plasty

Manufacturer

Perouse Plasty