Events

Alerta De Seguridad para Femoral Ceramic Head, Alumina, with anchorages (Chrome-Cobalt Taper) 12/14: (1) 26 mm Diameter / + 0 mm Collar Length, (2) 26 mm Diameter / +3.0 mm Length Colo, (3) 26 mm Diameter / +3.5 mm Collar Length

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.

¿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
    696
  • Fecha
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The data resulting from the femoral head static compression test quoted above indicated that there was no compliance with the specifications required for the critical reference levels [see "fda guidance document for the preparation of premarket notifications for ceramic ball hip systems"]. the manufacturer initiated a recall by letter dated january 6, 2003.
  • Acción
    Verify that you received the Zimmer notification letter and questionnaire on January 6, 2003. Identify and isolate any affected product in your inventory, protect the product from future use, and contact your local Zimmer representative who will return the product to Zimmer. ANVISA recommends that you locate all the units mentioned above that have been deployed in your institution and by whom. Inform the surgeons who proceed the implants that the product has been subject to a recall. The surgeon must decide whether medical intervention in the patient who received the implant is necessary. Total credit will be given for the returned product. Return the notification questionnaire by mail using the pre-addressed or faxed envelope to Connie Morgan at 0021-1 (574) 372-4265. For further information, please contact your local Zimmer representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Femoral Ceramic Head, Alumina, with anchorages (Chrome-Cobalt Taper) 12/14: (1) 26 mm Diameter / ...

Manufacturer

Zimmer Inc
  • Source
    ANVSANVISA