Events

Safety Alert for Arion silicone breast prosthesis, Record nº 80165560006

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Imact Importação e Comércio Ltda; Laboratoires Arion.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1493
  • Date
    2014-12-29
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    The company must take action to collect the product.
  • Reason
    In the process of maintaining the use of the seal of conformity identification (product certification), during a factory audit, it was verified that the company adopts two methods of sterilization, ethylene oxide and dry heat, only the sterilization method by ethylene oxide is included in the product registration process.
  • Action
    Publication of Resolution RE No. 4.881, of December 19, 2014, as described below: "Art. 1º To determine, as a measure of sanitary interest, in the whole national territory, the suspension of the importation, distribution, commercialization and implantation of the product MOLECULAR PROSTHETICS OF SILICONE ARION, which includes on the label the information of sterilized by dry heat in registration No. 80165560006, manufactured by Laboratoires Arion, located in France, registered by Imact Importação e Comércio Ltda. (CNPJ: 03.400.037 / 0001-03). Article 2. To determine, as a measure of sanitary interest, throughout the national territory, the suspension of the importation, distribution, commercialization and implantation of the product PROSTHETIC MOLECULAR SILICONE ARION sterilized by ethylene oxide, registration 80165560006, manufactured from 28/4 / 2014 by the company Laboratoires Arion, located in France, registered by Imact Importação e Comércio Ltda. (CNPJ: 03.400.037 / 0001-03). Art. 3 To determine that the company Imact Importação e Comércio Ltda. promote the collection of existing stock in the market for the products described in arts. 1st and 2nd. "

Device

Arion silicone breast prosthesis, Record nº 80165560006

Manufacturer

Imact Importação e Comércio Ltda; Laboratoires Arion
  • Source
    ANVSANVISA