Events

Alerta De Seguridad para Trade name: MDN FEM Long and Versa FX Supracondylar 16-20 F Registration number ANVISA: 80245480016, 80245480014 Hazard class: III Serial numbers affected: 00368898; 00368898R; 00370907; 26060100V; 60518281; 60812398R; 6,157,7082; 62351559; 62445941; 62539606; 62930529; 37214361; 60165193; 60482973; 60533011; 6,251,128; 37109081; 60598295; 24397300V; 60680624; 60758098; 61307908; 61413333; 61313655; 60732923; 61357112; 60615904; 6,114,354; 6,114,828; 61389801; 60615906; 22195400V; 60565839; 61450097; 22299700; 6,142,220; 60477024.

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
    2292
  • Fecha
    2017-05-17
  • 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
    Report adverse effects related to these products in Brazil directly to the local sales representative, or: On line: www.wmie.com.br, or www.anvisa.gov.br, or www.fda.gov/medwatch/report.htm , or Tel / Fax: 21 2210-2620 E-mail: sac@wmie.com.br, or zimmer.per@zimmer.com. If after reading this notification you have additional doubts please contact your local Zimmer distributor, or WM 21 2210-2620 (Monday - Friday from 8:30 am to 6pm), or Zimmer SAC 1-877-946-2761 Additional Information: This Recall volunteer was reported to ANVISA and the US Food and Drug Administration (FDA)
  • Causa
    Zimmer biomet is initiating a voluntary recall of some sterile implants due to the possibility of packing failure, the affected products are the longer length rods, the manufacturer zimmer biomet is collecting the potentially affected products remaining in stock. the affected lots were distributed to brazil since aug / 2007 and no injury or damage was reported for this event.
  • Acción
    Field Action Code ZFA - 2017 - 139 triggered under the responsibility of the company WM WORLD MEDICAL IMP EXP LTDA. Company will make collection for later return to the manufacturer.

Device

Trade name: MDN FEM Long and Versa FX Supracondylar 16-20 F Registration number ANVISA: 802454800...

Manufacturer

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