Events

Alerta De Seguridad para DENTAL IMPLANTS - Model 140.683 IMPLANT DRIVE CM 3.5 X 13.0 ACQUA, Registration nº 10344420072 - Lote- 800111242 (Implant Drive CM 3.5x13 Acqua) and lot 800100234 (Implant Drive Ti (3.3) 3.5x13)

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
    1387
  • Fecha
    2014-05-09
  • 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 are carried out according to the external label, so the dentist surgeon would prepare to install a Drive Acqua CM implant and could not finish the surgery, for finding a Drive Ti implant.
  • Causa
    The company that holds the registration informs about the possible exchange of labels on the external packaging of the product. drive ti 3.5x13 mm implants (item 109755) were labeled as implante drive acqua cm 3.5x13 mm (item 140.683).
  • 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

DENTAL IMPLANTS - Model 140.683 IMPLANT DRIVE CM 3.5 X 13.0 ACQUA, Registration nº 10344420072 - ...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.