Events

Retiro De Equipo (Recall) de INSERT PE TRIANON

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 FH ORTHOPEDICS.

¿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
    2009-01-29
  • 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-insert-pe-trianon-fh-orthopedics
  • 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 29/01/09 the company FH ORTHOPEDICS removed from the market the lots mentioned in the appendix of the medical device called INSERT PE TRIANON, manufactured by FH Industrie following a labeling error on the second packaging of this device on which it is mentioned ' 'Sterile' when it is not, only the bag in contact with the implant must be marked '' Sterile '' .. The company FH ORTHOPEDICS has directly notified the recipients of the incriminated lots using the attached message (29/01/2009) (17 KB) validated by the Afssaps This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned The competent European authorities concerned are informed of this measured by the manufacturer.

Device

INSERT PE TRIANON
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    FH ORTHOPEDICS

Manufacturer

FH ORTHOPEDICS