Events

Alerta De Seguridad para damon 3mx bicuspid brackets

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

¿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
    2012-04-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120417.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: damon 3mx bicuspid brackets medical device manufacturer, ormco corporation, is conducting a recall on one lot of damon 3mx bicuspid brackets due to an identification error. according to sybron dental specialties, inc., a company representing ormco corporation, the brackets should have a purple colored id dot to identify them as maxillary bicuspid brackets, but the affected lot was produced with dark blue colored id dots, which identify them as maxillary central incisor brackets. sybron dental specialties confirmed that the affected lot has not been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

damon 3mx bicuspid brackets
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Damon 3MX Bicuspid Brackets
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation