Events

Alerta De Seguridad para DENTAL IMPLANTS - Model 140692 IMPLANT DRIVE CM 3.5 X 8.0 ACQUA, Registration nº 10344420072 - Lote- 800170628

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
    1541
  • Fecha
    2015-02-23
  • 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 manifestation of the company, if the professional has not observed the failure prior to the surgical procedure or observes during its accomplishment and does not have another unit of item 140.692 for replacement, the conclusion of the surgery to implant the implant may be unfeasible, compromising the aesthetic and functional reestablishment of the patient.
  • Causa
    The company that holds the registration informs about the absence of the implant in the product packaging, lot 800170628, item 140.692.
  • Acción
    The company that registers in Brazil advises dental surgeons to entrust their inventories and forward the units of nonconforming product to Neodent.

Device

DENTAL IMPLANTS - Model 140692 IMPLANT DRIVE CM 3.5 X 8.0 ACQUA, Registration nº 10344420072 - Lo...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.