Events

Retiro De Equipo (Recall) de I-CONE (ICC) and HE Dental Implants

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 Medical Production.

¿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
  • ID del evento
    201603252
  • Fecha
    2016-03-02
  • 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/implants-dentaires-i-cone-icc-et-he-medical-production-rappel-de-produit
  • 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 ANSM has been informed of the implementation of a product withdrawal carried out by the company MEDICAL PRODUCTION .. The users concerned have received the attached mail (02/03/2016) (103 KB). This safety action is registered with the ANSM under the number 201603252. You will be able to consult its progress status on the Directory of materiovigilance reports by entering this registration number. Read too. Decision of 11/02/2016 suspending the manufacture, placing on the market, export, distribution and use of dental implants of the references ICC (I-CONNE) and HE put on the market by the company MEDICAL PRODUCTION as well as withdrawal of these products (16/02/2016) (676 ko)

Device

I-CONE (ICC) and HE Dental Implants
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Medical Production

Manufacturer

Medical Production