Events

Alerta De Seguridad para WIRES ZIMMER GUIDES, Models 2228-24, 47-2237-33 - Registration - 80245480007 - Lots 60996288, 61030793, 61020362, 61030778, 61020362; Models 2255-25, 2255-26, Registry 80245480015 - 60701262, 61291089, 61330039, 61723543, 61745826.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por WM WORLD MEDICAL IMP EXP LTDA; 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
    1683
  • Fecha
    2015-09-10
  • 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
    The company informs that Zimmer Biomet has received no complaints or notices of adverse events involving products related to this field action. 192 units were consumed in Brazil and there are no products in stock. The affected items were distributed from January 2006 to February 2015. The commercialization of affected lots in Brazil was restricted to Rio de Janeiro. No units of the lots involved in this field action were identified.
  • Causa
    By reviewing the packaging stability tests, it was found that the labeling of the guidewires affirmed an expiry date of 10 years while the tests support a 5 year expiry date for those guidewires. zimmer biomet is collecting all non-expired batches of marked guide wires with a shelf life of 10 years.
  • Acción
    The company advises you to contact your local Zimmer distributor, or WM 21 2210-2620 (Monday - Friday from 8:30 am to 6:00 pm), or Zimmer SAC 1-877-946-2761, Tel / Fax: 21 2210-2620, E-mail: sac@wmie.com.br, or zimmer.per@zimmer.com.

Device

WIRES ZIMMER GUIDES, Models 2228-24, 47-2237-33 - Registration - 80245480007 - Lots 60996288, 610...

Manufacturer

WM WORLD MEDICAL IMP EXP LTDA; ZIMMER INC
  • Source
    ANVSANVISA