Events

Safety Alert for # Business name: BIOSSIMETRIC. # Registration number: 80434370001. # Risk Class: III - HIGH RISK. # Technical Name: Implant For Repairing Plastic. # Presentation: BIOSSIMETRIC 5%; BIOSSIMETRIC 10%; BIOSSIMETRIC 15% ;. BIOSSIMETRIC 30%

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MTC Medical Comércio, Indústria, Importação e Exportação de Produtos Biomédicos Ltda.

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
    1281
  • Date
    2013-08-15
  • 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
    As a measure of sanitary interest, the company must make a payment of ALL LOTS distributed that may be available for consumption. # On 09/16/2013: Application for the granting of a Certificate of Good Manufacturing Practices for Medical Products pursuant to Resolution RE 3366, dated September 12, 2013, published in DOU No. 179 - Supplement - page 109, of 16 / 09/2013 # # On 09/30/2013: Canceled the Certificate of Good Practices of Manufacture of Medical Products of the company MTC Medical Commerce, Industry, Import and Export of Biomedical Products Ltda - CNPJ 08.996.736 / 0001-73 according to Resolution RE No. 3585 of September 26, 2013, published in DOU No. 189 - Section 1 - page 68, of 09/30/2013
  • Reason
    The company does not comply with good manufacturing practices for health products. # update # the marketing and implantation of all lots of product is prohibited. all lots must be collected by company #.
  • Action
    Suspension of the manufacture, distribution, dissemination, trade and implantation, throughout the national territory, of the product BIOSSIMETRIC, determined by ANVISA according to RE No. 2.923, of August 14, 2013, published in the DOU Nº 157 - Section 1, of August 15 / 2013, page 52 # UPDATE # SEE ALSO 1. RE 5.139 / 2012 - DOU 234 - Section 1 - Page 63; 2. OFFICE OF THE DIRECTOR OF 08/14/2013 (DOU 157, of 08/15/2013 - Page 53). # UPDATE (09/16/2013) The application for the granting of a Certificate of Good Manufacturing Practices for Medical Products pursuant to Resolution RE 3366, of September 12, 2013, published in DOU No. 179 - Supplement - page 109, of 09/16/2013 # # UPDATE (09/30/2013) Canceled the Certificate of Good Practices of Manufacture of Medical Products of the company MTC Medical Comércio, Indústria, Importação e Exportação de Produtos Biomédicos Ltda - CNPJ 08.996.736 / 0001-73 pursuant to Resolution RE No. 3585, dated September 26, 2013, published in DOU No. 189 - Section 1 - page 68, of 09/30/2013 # # UPDATE (05/19/2014) Partially revoked Resolution RE 2923/2013 by Resolution RE No. 1848/2014, published in DOU No. 92, Section 1, dated 05/16/2014, page 53, which released the manufacture, distribution, distribution, trade and implantation of the Biossimetric product, manufactured from 05/05 / 2014.

Device

# Business name: BIOSSIMETRIC. # Registration number: 80434370001. # Risk Class: III - HIGH RISK....

Manufacturer

MTC Medical Comércio, Indústria, Importação e Exportação de Produtos Biomédicos Ltda
  • Source
    ANVSANVISA