Events

Retiro De Equipo (Recall) de Cemented PF femoral stems, 11.7 mm thin 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
    2004-08-23
  • 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/rappel-de-tiges-femorales-de-protheses-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
    Centerpulse informed AFSSAPS on August 18, 2004, that it was recalling all batches of cemented PF femoral stems, 11.7 mm thin neck, with a half-moon of impaction centered. Although no breakage of these femoral stems was reported in materiovigilance, Centerpulse took this action following the various recalls made on similar devices of different brand design. Users of this device have received the attached mail (23/08/2004) (16 KB). The other competent European authorities have not been informed of this measure, France being the only country concerned by this recall. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to orthopedic surgeons.

Device

Cemented PF femoral stems, 11.7 mm thin neck
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Centerpulse

Manufacturer

Centerpulse
  • Source
    LAANSM