Events

Retiro De Equipo (Recall) de Cereform Silicone Gel filled Breast Implants and Corresponding Sizers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical Vision Aust Plastic & Cosmetic Pty Ltd.

¿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
    RC-2014-RN-00161-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-06
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00161-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    French regulatory body, ansm after an inspection of the manufacturing facility determined that the validation of the sterilisation provider was not consistent with the requirements of international regulatory standards. therefore, sterility of the cereform breast implants and corresponding sizers cannot be fully assured. cereplas was in the process of validating a new sterilisation provider but due to the lengthy process of such validation cereplas did not meet the deadline set by the french regulatory body ansm resulting in suspension of the ce certificate on the 10th february 2014. the suspension remains in place until the sterilisation validation with the new provider is completed and accepted by ansm. following the suspension of the ce certificate ansm requested that all non-implanted cereform products be recalled in france clearly stating the recall was based on the licensing and regulatory issue and not a “sanitary” (safety) issue.
  • Acción
    Medical Vision Australia Plastic & Cosmetic Pty Ltd has recalled all the non-implanted stock and is returning the recalled stock and all stock under their control to the manufacturer Cereplas, France. For more details, please see http://www.tga.gov.au/safety/alerts-device-cereform-breast-implants-140311.htm .

Device

Cereform Silicone Gel filled Breast Implants and Corresponding Sizers

Manufacturer

Medical Vision Aust Plastic & Cosmetic Pty Ltd