Events

Alerta De Seguridad para Implante Titamax CM Cortica I 3.5x11 - 800100435 and Implant Titamax Ti Cortical (4.1) 3.75x13 - 8000100163, Registry 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
    1397
  • 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 manifestation of the company, sales of the implants are carried out according to the external label of the product. The dentist surgeon would have in his hands a product not suitable for the product needed for surgery.
  • Causa
    The company holding the registration informs that there was a failure in the labeling process, with some units of the titamax ti cortical implant (4.1) 3.75x13 received the external tag of the titamax cm cortical 3.5x11 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

Implante Titamax CM Cortica I 3.5x11 - 800100435 and Implant Titamax Ti Cortical (4.1) 3.75x13 - ...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.