Events

Recall of AES ankle 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 Transystème SA.

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
    2008-12-29
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/suspension-de-la-commercialisation-des-protheses-de-cheville-aes-par-la-societe-transysteme
  • 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
    In agreement with Afssaps, the company Transforme, informed, on 09/12/08, the users of the AES ankle prostheses of the suspension of the marketing of this device. The users concerned, in France, have received the attached mail (29/12/2008) (28 ko). A survey conducted by Afssaps, intended to evaluate the rate of geodes and their evolution in patients with AES ankle prostheses, is currently underway. The competent European authorities have been informed of this measure by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services. Read auss. Information / recommendation concerning AES ankle prostheses manufactured by Transystème SA and marketed by Biomet France

Device

AES ankle prostheses
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Transystème SA

Manufacturer

Transystème SA
  • Source
    LAANSM