Events

Alerta De Seguridad para Trade name: PROTESE FOR ARTHROPLASTY OF QUADRIL META BIO CO-CR-MO ## Record: 80034760016 - List of products under risk in Brazil (ATTACHMENT)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Meta Bio Industrial Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1505
  • Fecha
    2015-02-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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 in the Traceability Labels sent to each product) , must be reported to the Distributor and Meta Bio. "
  • Causa
    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).
  • Acción
    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

Trade name: PROTESE FOR ARTHROPLASTY OF QUADRIL META BIO CO-CR-MO ## Record: 80034760016 - List o...

Manufacturer

Meta Bio Industrial Ltda.