Events

Alerta De Seguridad para K3 Gutta Percha

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Sybron Dental Specialties.

¿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
  • Fecha
    2012-02-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120223b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: sybronendo k3 gutta percha medical device manufacturer, sybron dental specialties, inc., has issued a field safety notice concerning the recall of one lot of k3 gutta percha. the manufacturer found that one lot of k3 gutta percha box labeled as part number 825-0625, which is the red-band #25 tip gutta percha, actually contain blue-band #30 tip gutta percha (part number 825-0630). according to the manufacturer, the product will function as expected and there are no safety or efficacy issues. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

K3 Gutta Percha
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SybronEndo K3 Gutta Percha
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties