Events

Retiro De Equipo (Recall) de Biological Matrix - Strattice

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 Lifecell Corporation.

¿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
    2015-07-06
  • 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/matrice-biologique-strattice-lifecell-corporation-retrait-de-produit
  • 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
    Decision repealed on 12/08/201. Following a public health decision of 25/06/2015 prohibiting the placing on the market, distribution, import and use of the medical device Strattice, in the indication of breast reconstruction, placing on the market by LIFECELL CORPORATION, as well as the withdrawal of these medical devices as they mention this indication, the company LIFECELL CORPORATION, informed the users of the Strattice of the product recall on 01/07/2015. Users concerned , in France, have received the attached letter (06/07/2015) (222 KB). The competent European authorities have been informed of this measure by the ANSM. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.

Device

Biological Matrix - Strattice

Manufacturer

Lifecell Corporation
  • Source
    LAANSM