Events

Retiro De Equipo (Recall) de zirconia heads 28/0 - Depuy Companies, Hospital Supplies, Smith + Nephew

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 Depuy.

¿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
    2001-07-23
  • 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-tetes-zircone-28-0-societes-depuy-fournitures-hospitalieres-smith-nephew
  • 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
    About thirty cases of rupture of ceramic heads of hip prostheses marketed by the company Depuy have been reported as part of materiovigilance. It has been shown that the femoral heads concerned by these ruptures are from a single batch Manufacturer Saint-Gobain Advanced Ceramics Demarquets, comprising 684 pieces. Three other manufacturers also received parts of this lot: Smith + Nephew France, Hospital Supplies Industry, Smith + Nephew USA .. The recall of all non-implanted parts was done by the four manufacturers concerned. Information for health facility and orthopedic directors who received these implants was distributed by manufacturers Depuy and Smith + Nephew so that patients would be aware of the high risk of early rupture of these implants.

Device

zirconia heads 28/0 - Depuy Companies, Hospital Supplies, Smith + Nephew
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Depuy

Manufacturer

Depuy