Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by WM WORLD MEDICAL IMP EXP LTDA; ZIMMER INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1705
  • Date
    2015-10-27
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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