Events

Retiro De Equipo (Recall) de Gripper batches from the Trident range

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
    2007-02-05
  • 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-de-pince-de-prehension-de-la-gamme-trident-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    The STRYKER company has withdrawn from the market on February 2nd, 2007 all the lots beginning with V1xxxx of the medical device called "gripper of the range TRIDENT" reference 2105-0000 used in orthopedics (hip), following an incompatibility between the ends of the pliers and the width of the positioning holes of the inserts of this range. The company has directly notified the recipients of the incriminated lots with the enclosed message (02/02/2007) (24 KB) validated by Afssaps. This information is addressed to the directors of health establishments, the local correspondents of materiovigilance and the supervisors of block for diffusion, if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Gripper batches from the Trident range
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

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