Events

Recall of Alumina head diameter 28 mm, 8/10 cone, short neck

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 Centerpulse.

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
    2004-10-18
  • 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-lots-de-tete-alumine-de-prothese-totale-de-hanche-de-la-societe-centerpulse
  • 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 Afssaps was informed on October 6, 2004 by the company Centerpulse of a withdrawal of the market on October 5, 2004 from all lots of the medical device called alumina head diameter 28 mm, 8/10 cone, short neck, reference 15.13.28.05 following a risk of rupture of these heads .. The health institutions concerned by this recall were warned directly using the message attached (03/10/2004) (12 ko) .. This information is for to the directors and local correspondents of materiovigilance for diffusion to the services concerned. The other competent European authorities were not informed of this measure, France being the only country concerned by this recall. Courrier Centerpulse (03/10/2004) (12 KB)

Device

Alumina head diameter 28 mm, 8/10 cone, short neck
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Centerpulse

Manufacturer

Centerpulse
  • Source
    LAANSM