Events

Retiro De Equipo (Recall) de Endopathic magazine 35mm ets, 35mm endopathic linear staplers, 35mm endopathic stapled articular staplers

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 Ethicon.

¿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
    2008-05-14
  • 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/chargeur-endopath-ets-35-mm-agrafeuses-lineaires-coupantes-endopath-ets-35-mm-agrafeuses-lineaires-articulees-coupantes-endopath-ets-flex-35-mm-ethicon-sas
  • 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
    On 09/05/2008, the company ETHICON SAS has withdrawn from the market the lots mentioned in annex of the named medical devices. ENDOPATH ETS 35 MM LOADER, references TR35W and TR35W. ENDOPATH ETS 35 MM CUTTING LINEAR STAPLES, reference TSW3. ENDOPATH ETS flex 35MM CUTTING LINEAR STAPLES, reference ATW35. manufactured by Ethicon Endo surgery, following the identification of a component defect involved in the production of the chargers and which may be at the origin of the formation of incomplete staple lines. The company ETHICON SAS has directly notified the recipients of the incriminated lots with the message attached (09/05/2008) (56 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Endopathic magazine 35mm ets, 35mm endopathic linear staplers, 35mm endopathic stapled articular ...
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon