Events

Alerta De Seguridad para Implant Titamax Ti EX (4.1) 3.75x13 - lot 800080809 and Implant Titamax Ti Cortical (5.0) 5.0x9 - lot: 800080529, 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
    1396
  • Fecha
    2014-06-06
  • 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, the sales of the implants are performed according to the external label of the product, the dental surgeon would prepare to perform surgery for the installation of an implant Ti EX and could not finish the surgery for finding a Ti implant cortical instead. Could not finish the surgery by having an implant for different purpose and size divergent than expected.
  • Causa
    The company that owns the registration reports a failure in the labeling process, and some units of the titamax ti cortical implant (5.0) 5.0x9 received the external label of the titamax ti ex (4.1) 3.75x13 implant.
  • Acción
    The company that registers in Brazil informs that its commercial advisers will visit the dentists who purchased this lot of the product to confirm if there was a failure in the labeling and to make the exchange and the collection of products with diversion.

Device

Implant Titamax Ti EX (4.1) 3.75x13 - lot 800080809 and Implant Titamax Ti Cortical (5.0) 5.0x9 -...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.