Events

Alerta De Seguridad para Implant Titamax Ti Cortical (4.1) 4.0x13 - lot: 800098936, Registration nº 10344420031

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
    1481
  • 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 manifestation of the company, if the dentist has a unit that is not compliant, it can not complete the installation of the implant, since it would be trapped in the packing ring. If the dentist can remove the implant from the package, there is no risk of its use, since the implant is in accordance with the specifications.
  • Causa
    The company holding the registration informs that it has been identified, after customer complaint, that some packages of the titamax ti cortical (4.1) 4.0x13 implant received the upper ring, which supports the implant inside the package, of a size smaller than specified. in this way, the implants contained in these packages remain attached to the ring.
  • Acción
    The company that registers in Brazil advises dental surgeons to check their inventories and, if they identify products from the field action lot, send them to Neodent.

Device

Implant Titamax Ti Cortical (4.1) 4.0x13 - lot: 800098936, Registration nº 10344420031

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.