Events

Alerta De Seguridad para HEAD FEMALE CERAMIC ALUMINA ZIMMER.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ZIMMER INC. (EUA); ARTHROTECH IMPORTAÇÃO EXPORTAÇÃO LTDA.

¿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
    1036
  • Fecha
    2010-11-26
  • 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
    Resolution RE No. 5,371, dated November 24, 2010, determining the suspension of the importation, distribution, trade and implantation, throughout the national territory, of all lots of the FEMALE CERAMIC ALUMINA ZIMMER HEAD product manufactured by ZIMMER INC., USA and imported by the company ARTHROTECH IMPORTAÇÃO EXPORTAÇÃO LTDA (CNPJ 02.348.439 / 0001-35), located at Av. Marechal Câmara, 350 Sala 901 - Centro, Rio de Janeiro - RJ, or by any other companies, for not having registered with this Agency .
  • Causa
    Product not registered in anvisa.
  • Acción
    Suspension of importation, distribution, trade and implantation, throughout the national territory, of all lots of the product HEAD FEMORAL CERAMIC ALUMINA ZIMMER.

Device

HEAD FEMALE CERAMIC ALUMINA ZIMMER.

Manufacturer

ZIMMER INC. (EUA); ARTHROTECH IMPORTAÇÃO EXPORTAÇÃO LTDA
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    ANVSANVISA