Events

Recall of Prostheses from EUROSILICONE laboratories

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 EUROSILICONE.

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
    2001-11-05
  • 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-de-protheses-des-laboratoires-eurosilicone
  • 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
    Several EUROSILICONE laboratory prostheses have been subjected to multiple sterilizations. Since this is a practice that has not been validated before being placed on the market and whose impact on products is unknown, Afssaps, in agreement with the EUROSILICONE laboratories, has decided to withdraw all these prostheses. The number of recipients being reduced, they were warned directly by the laboratory. All prostheses whose serial number begins with the letters A, B, C or D are affected and must be removed. As well as prostheses having the serial number E094I001, G175L018, E278I012, E286I010, E300I009 and E302I019. The elements at our disposal are not likely to jeopardize the safety of the patients to whom these prostheses were implanted. Nevertheless, an evaluation is in progress. No case of materiovigilance has been reported so far. Any time, it will be advisable to report to the material vigilance unit of the Afssaps (tel: 01 55 87 40 24 and fax: 01 55 87 37 02), any abnormality possibly found in these patients.

Device

Prostheses from EUROSILICONE laboratories
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    EUROSILICONE

Manufacturer

EUROSILICONE
  • Source
    LAANSM