Events

Alerta De Seguridad para Angle Meter 17 degrees - Model 128017, lot 800069008, Registration No. 10344420037.

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
    1480
  • 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, when performing the surgical procedure for implant installation, the dentist will incorrectly measure the angulation of the perforation performed. Thus, the choice of component angulation will be performed incorrectly, which may compromise the inclination of the prosthesis and, consequently, its aesthetics and function, and it may be necessary to change the component and perform a new prosthesis.
  • Causa
    The record company informs that it has identified, through customer complaint, that the angulation information of the 17 degree angle meter product, recorded on parts of lot 800069008, is incorrect. recorded information: 30 degrees; correct information: 17 degrees.
  • Acción
    The company that registers in Brazil advises dentists to check their inventories and, if they identify products from the lots that are the target of the field action, send them to Neodent.

Device

Angle Meter 17 degrees - Model 128017, lot 800069008, Registration No. 10344420037.

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.