Events

Recall of IMGHC-TX

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 POLY IMPLANTS PROTHESES.

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
    2001-06-29
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-du-lot-06701-de-protheses-mammaires-preremplies-de-gel-de-silicone-reference-imghc-tx-de-la-societe-poly-implants-protheses
  • 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 batch 06701 of silicone gel pre-filled breast prosthesis, reference IMGHC-TX, of the company POLY IMPLANTS PROTHESES is withdrawn from the market, because of a non-conformity, with respect to the technical specifications, of the proportions of the two parts of the gel of silicone (filler). The elements at our disposal are not likely to jeopardize the safety of the patients to whom this prosthesis has been implanted.

Device

IMGHC-TX

Manufacturer

POLY IMPLANTS PROTHESES
  • Source
    LAANSM