Events

Retiro De Equipo (Recall) de ABU PHY - SSABU, IOTA Implant - IOT, THETA - THE Implant, Cylindrical Implant - ALPHA, Cylindrical Implant - PHY, Membrane Implant - TAU

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 Ethical Medical Implants (EMI).

¿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
    R1711454
  • Fecha
    2017-07-19
  • 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/implant-dentaire-abu-phy-ssabu-implant-iota-iot-implant-theta-the-implant-cylindrique-alpha-implant-cylindrique-phy-implant-membrane-tau-ethical-medical-implants-emi-retrait-de-produits
  • 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
    ANSM has been informed of the implementation of a withdrawal of product by the company ETHICAL MEDICAL IMPLANTS (EMI). The affected users have received the attached mail. (19/07/2017) (125 KB) This safety action is registered with the ANSM under the number R1711454 Read also Decision of 20/06/2017 suspending manufacture, placing on the market, export , distribution and use of medical devices for dental implantology marketed by the company ETHICAL MEDICAL IMPLANTS (EMI) and manufactured from the reference raw material VESTAKEEP 4000P, as well as the removal of these products (29 / 06/2017) (1509 KB)

Device

ABU PHY - SSABU, IOTA Implant - IOT, THETA - THE Implant, Cylindrical Implant - ALPHA, Cylindrica...

Manufacturer

Ethical Medical Implants (EMI)
  • Source
    LAANSM