Events

Safety Alert for MISCELLANEOUS METAL IMPLANTS - see detailed description of the affected products and lots at: http://portal.anvisa.gov.br/wps/wcm/connect/e6d196804a271260b125b9aa19e2217c/Alerta_1113_RE_218_2012.pdf?MOD=AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMECÂNICA INDÚSTRIA E COMÉRCIO DE PRODUTOS ORTOPÉDICOS LTDA. CNPJ: 58.526.047/0001-73. Endereço: Rua Luiz Pengo, 145, 1° Distrito Industrial Jaú – SP..

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
    1113
  • Date
    2012-01-13
  • 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
    During the manufacturer's fiscal inspection from 09 to 10/11/2011, evidence of use of improper raw material for human implantation - 316L stainless steel, ASTM A240 / 08, ASTM A240 / 06, ASTM A240 / 240M-08, ASTM A276 / 05, ASTM A276 / 06 and ASTM A269. The results of the inspection led to the publication of RE n ° 218/2012 by ANVISA, determining the suspension, throughout the national territory, of the distribution, marketing and implantation of the products mentioned in this alert. For more complete information on the use of 316L steel in metal implants, please refer to the texts of the Technovigilance Newsletter Special Edition / 2011, available at: http://www.anvisa.gov.br/boletim_tecno/boletim_tecno_de Dezembro_ed_especial/boletim_tecno.html
  • Reason
    Products manufactured with raw material inadequate for orthopedic implant.
  • Action
    Health care establishments or distributors holding the affected products shall suspend their implantation, commercialization or distribution, as defined in Resolution RE n ° 218 of January 25, 2012. Products must be segregated and identified to avoid inadvertent use. In this case, the registration holder shall be notified to pay for the product (s) as determined by the abovementioned RE. In the case of products already implanted, health professionals should monitor their patients, evaluate the conditions of the implants over time, and notify Anvisa in the event of adverse events.

Device

MISCELLANEOUS METAL IMPLANTS - see detailed description of the affected products and lots at: htt...

Manufacturer

BIOMECÂNICA INDÚSTRIA E COMÉRCIO DE PRODUTOS ORTOPÉDICOS LTDA. CNPJ: 58.526.047/0001-73. Endereço...