Events

Alerta De Seguridad para ADJUSTER FOR CONNECTION CABINET FOR ANGLE - Model 105025, lots: 800116982, 800116984 and 800116985, Registration No. 10344420026

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A..

¿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
    1479
  • Fecha
    2014-11-28
  • 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
    According to the company's statement, if the dentist does not notice the instability in the socket and insists on installing the mini-implant, it may deform or fracture the same.
  • Causa
    The company holding the registration informs that it has identified, from customer complaint, that batches 800116982, 800116984 and 800116985 of the product for counter-angle connections ratchet adapter do not have the inner ring.
  • Acción
    The company that registers in Brazil advises dentists to check their inventories and, if they identify products from the lots that are the target of the field action, send them to Neodent.

Device

ADJUSTER FOR CONNECTION CABINET FOR ANGLE - Model 105025, lots: 800116982, 800116984 and 80011698...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.