Events

Alerta De Seguridad para Femoral Long Cephalomendular Rods ZNN, Models 47-2493-300-10, 47-2493-300-11, 47-2493-300-13, 47-2493-301-10, 47-2493-301-11, 47-2493 -301-13, 47-2493-302-10, 47-2493-303-10, 47-2493-320-10, 47-2493-320-11, 47-2493-320-13, 47-2493-321 -10, 47-2493-321-11, 47-2493-321-13, 47-2493-322-10, 47-2493-323-10, 47-2493-340-10, 47-2493-340-11 , 47-2493-340-13, 47-2493-341-10, 47-2493-341-11, 47-2493-341-13, 47-2493-342-10, 47-2493-343-10, 47 -2493-360-10, 47-2493-360-11, 47-2493-360-13, 47-2493-361-10, 47-2493-361-11, 47-2493-362-10, 47-2493 -363-10, 47-2493-380-10, 47-2493-380-11, 47-2493-380-13, 47-2493-381-10, 47-2493-381-11, 47-2493-381 -11, 47-2493-381-13, 47-2493-382-10, 47-2493-383-10, 47-2493-400-10, 47-2493-400-11, 47-2493-400-13 , 47-2493-401-10, 47-2493-401-11, 47-2493-401-13, 47-2493-402-10, 47-2493-403-10, 47-2493-420-10, 47 -2493-420-11, 47-2493-420-13, 47-2493-421-10, 47-2493-421-11, 47-2493-421-13, 47-2493-422-10, 47-2493 -422-10, 47-2493-423-10, 47-2493-423-10, 47-2493-440-10, 47- 2493-440-11, 47-2493-440-13, 47-2493-441-10, 47-2493-441-11, 47-2493-441-13, 47-2493-442-10, 47-2493- 443-10, 47-2493-460-10, 47-2493-460-11, 47-2493-460-13, 47-2493-461-10, 47-2493-461-11, 47-2493-461- 13 - Registration: 80245480060. Lots: All manufactured between December 2009 and July 2015.

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
    1705
  • Fecha
    2015-10-27
  • 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 no adverse effect or damage has been reported by virtue of this report. It is a routine part of hospitals, employees and health professionals to inspect the integrity of the packaging and seals, as well as to notify any importer or SNVS of any event. ALL IMPORTERS WERE COMMUNICATED AND INVENTORIES ISNPECATED AND NO ITEM PRESENTED DAMAGE TO PACKAGING.
  • Causa
    Zimmer gmbh conducted an internal packaging review in accordance with current packaging testing standards. during this evaluation, it was identified that a subset of the above referenced products require additional testing to ensure that the packs meet the established requirements. cephalomedullary rods are packaged in a double sterile barrier package, which includes placing the product in a protective bag and then into two sterile barrier trays (internal and external). in approximately 5% of the samples tested, the outer tray was compromised, but there were no records suggesting that the sterility of the inner tray was affected. the manufacturer has received no complaints alleging compromised packaging. possibly affected devices were distributed from december 2009 to july 2015. in the event of any damage to the carton and / or the inner tray, it is very likely to be detected prior to surgery. the package leaflet (instructions for use) supplied with the device or contains a section on sterility where it instructs the user to inspect the packaging and not to use the device if any seal or cavity is damaged. therefore, all affected products must be visually inspected for damage, and returned when damages are noticed.
  • 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

Femoral Long Cephalomendular Rods ZNN, Models 47-2493-300-10, 47-2493-300-11, 47-2493-300-13, 47-...

Manufacturer

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