Events

Retiro De Equipo (Recall) de Serfas electrodes 90 3.5 mm with suction

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 STRYKER.

¿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
    2007-05-16
  • 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-d-electrodes-serfas-de-la-societe-stryker
  • 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    The STRYKER company has withdrawn from the market on May 15, 2007 batches 06361AE2 to 07044AE2 of the medical device called "Serfas electrodes 90 3.5 mm with suction" reference 0279351100 used in arthroscopy following a risk of short circuit related to a liquid leak at the level of the handpiece. The company has directly notified the recipients of the incriminated lots with the message attached (15/05/2007) (23 KB) validated by Afssaps. This information is addressed to the directors of health establishments, local correspondents of materiovigilance and pharmacists for dissemination, where appropriate, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Serfas electrodes 90 3.5 mm with suction
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

STRYKER
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    LAANSM