Events

Safety Alert for QUATTRO VPS HAP 050mm, REF HQCHC050, QUATTRO VPS HAP 052mm, REF HQCHC052 and QUATTRO VPS HAP 054mm, REF HQCHC054. Lots: All

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ortocir Ortopedia Cirurgia Ltda.; Groupe Lepine.

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
    1669
  • Date
    2015-04-07
  • 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 resolution also determined that the company promotes the collection of existing stock in the market for the products cited.
  • Reason
    Products manufactured in chromium-cobalt alloy, but labeled in brazil as being manufactured in titanium.
  • Action
    Published Resolution RE 1,051 of April 6, 2015, determining the suspension of the distribution, commercialization and implantation of the aforementioned products, manufactured in Chromo-Cobalt alloy by the company Groupe Lepine, France, imported and re-labeled as being manufactured in Titanium.

Device

QUATTRO VPS HAP 050mm, REF HQCHC050, QUATTRO VPS HAP 052mm, REF HQCHC052 and QUATTRO VPS HAP 054m...

Manufacturer

Ortocir Ortopedia Cirurgia Ltda.; Groupe Lepine
  • Source
    ANVSANVISA