Events

Alerta De Seguridad para Trade name: Revision stem REVITAN Registration number ANVISA: 80199020016 Class of classification: III

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDSINTESE IMPORTAÇÃO EXPORTAÇÃO E COMÉRCIO EIRELI.; Zimmer GmbH.

¿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
    2250
  • Fecha
    2017-03-30
  • 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
    Bone material of adequate quality must exist and should be evaluated at the time of surgery. In patients with severe proximal deficiency, the surgeon should consider surgical options for securing proximal bone support (eg, medial and / or lateral support graft) or switching to a monobloc revision shaft, such as the Wagner SL Hip Shank Revision.
  • Causa
    The notice is intended to inform you that zimmer gmbh is voluntarily conducting a medical device field safety notice for the revita review system. this field safety notice informs the use of the revitan review system and is delivered in conjunction with the latest updates to the surgical techniques of reference 06.01169.012x-ed 2016.11-ver.03 (revitan curves) and 06.01109.012x- ed 2016.11-ver 04 (revita retas) 1. zimmer gmbh would like to emphasize that the selection of patients for the modular hip revision systems, such as the revitan system, is an essential parameter.
  • Acción
    Field Action Code FA 2017-01 triggered under the responsibility of the company MEDSINTESE IMPORT EXPORT AND TRADE EIRELI. Company will make safety notice.

Device

Trade name: Revision stem REVITAN Registration number ANVISA: 80199020016 Class of classification...

Manufacturer

MEDSINTESE IMPORTAÇÃO EXPORTAÇÃO E COMÉRCIO EIRELI.; Zimmer GmbH
  • Source
    ANVSANVISA