Events

Safety Alert for ACETABULAR COMPONENT OF POLYETHYLENE META BIO (registration no. 80034760015), PRÓTESE FOR ARTHROPLASTY OF META BIO HIP - Co-Cr-Mo (registration nº 80034760016) and PRÓTESE FOR ARTHROPLASTY OF META BIO TITÂNIO HIP (registry nº 80034760017).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Meta Bio Industrial Ltda..

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
    1512
  • Date
    2014-12-19
  • 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 Meta Bio Industrial Ltda - CNPJ 02513989 / 0001-62, NOTIFIED to complete and send the Field Action Notification Form, and subsequently, the other forms as provided in IN 001/2012 of RDC 23/2012. GEMOR - Management of Risk Monitoring, will be monitoring the stock collection actions in the market.
  • Reason
    Possibility of the existence of products already marketed that may present some variation as to sphericity requirements,.
  • Action
    Gathering stock on the market

Device

ACETABULAR COMPONENT OF POLYETHYLENE META BIO (registration no. 80034760015), PRÓTESE FOR ARTHROP...

Manufacturer

Meta Bio Industrial Ltda.