Events

Retiro De Equipo (Recall) de Plate INTRAMESH T1

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 COUSIN BIOTECH.

¿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
    2007-06-01
  • 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-plaque-intramesh-t1-cousin-biotech
  • 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
    In agreement with Afssaps, on May 30, 2007, the company COUSIN BIOTECH proceeded with the recall of batches of the medical device called Plate INTRAMESH T1 references FBIOT12020, FBIOT12025, FBIOT13030 and FBIOT13050, following the highlighting of a weakness of the implant due to a limit value of the textile raw material, which can lead to embrittlement under severe mechanical stress. The company has directly notified the recipients of the incriminated lots with the message attached (01/06/2007) (27 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 competent European authorities concerned are informed of this measure by Afssaps.

Device

Plate INTRAMESH T1
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    COUSIN BIOTECH

Manufacturer

COUSIN BIOTECH
  • Source
    LAANSM