Events

Safety Alert for COMPONENTS ACETABULAR CIEENTED OF POLYETHYLENE META BIO - Registry 80034760015 - List of products under risk in Brazil (ATTACHMENT)

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
    1504
  • Date
    2015-02-04
  • 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
    Company recommendations to users and patients: "Through the publication of the Resolution, we recommend to users and patients that there is some type of adverse event involving the products mentioned in the Collection Action (which can be verified on the Traceability Labels sent to each product) , must be reported to the Distributor and Meta Bio. "
  • Reason
    Possibility of existence of products already marketed that may present some variation regarding sphericity requirements, according to normative requirement (nbr iso 7206-2 and nbr iso 21534).
  • Action
    The company is doing the Recall of the batches manufactured before 7/23/2014. (List in ANNEX). Company is communicating its distribution chain so that it divulges to its clients (health services) (Letter in ANNEX).

Device

COMPONENTS ACETABULAR CIEENTED OF POLYETHYLENE META BIO - Registry 80034760015 - List of products...

Manufacturer

Meta Bio Industrial Ltda.