Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOMECÂNICA INDÚSTRIA E COMÉRCIO DE PRODUTOS ORTOPÉDICOS LTDA. CNPJ: 58.526.047/0001-73. Endereço: Rua Luiz Pengo, 145, 1° Distrito Industrial Jaú – SP..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1113
  • Fecha
    2012-01-13
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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
  • Causa
    Products manufactured with raw material inadequate for orthopedic implant.
  • Acción
    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...