Events

Rappel de Cereform Silicone Gel filled Breast Implants and Corresponding Sizers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical Vision Aust Plastic & Cosmetic Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00161-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-06
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00161-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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