Events

Alerte De Sécurité sur HEAD FEMALE CERAMIC ALUMINA ZIMMER.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ZIMMER INC. (EUA); ARTHROTECH IMPORTAÇÃO EXPORTAÇÃO LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1036
  • Date
    2010-11-26
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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 .
  • Cause
    Product not registered in anvisa.
  • Action
    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
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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