Events

Retiro De Equipo (Recall) de Alumina head diameter 28 mm, 8/10 cone, short neck

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Centerpulse.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2004-10-18
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    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
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Centerpulse

Manufacturer

Centerpulse
  • Source
    LAANSM