Events

Safety Alert for 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.

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
    1683
  • Date
    2015-09-10
  • 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 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.
  • Reason
    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.
  • 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

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