Events

Alerta De Seguridad para NobelProcera Abutment Zr for Straumann Bone Lvl NC 3.3

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

¿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
    2012-07-13
  • Fecha de publicación del evento
    2012-07-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120713a.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
    Medical device safety alert: nobel biocare nobelprocera abutment zr for straumann bone lvl nc 3.3 medical device manufacturer, nobel biocare issued a medical device safety alert concerning nobelprocera abutment zr for straumann bone lvl nc 3.3. nobel biocare has become aware through customer complaint that selected abutments of nobelprocera abutment zr for straumann bone lvl nc 3.3 have been machined incorrectly. the abutment consists of a zirconia portion and an adapter portion that fits into the implant. the adapter portion was machined larger than specifications. the abutment will therefore not fit into the implant. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 july 2012.

Device

NobelProcera Abutment Zr for Straumann Bone Lvl NC 3.3
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Nobel Biocare NobelProcera Abutment Zr for Straumann Bone Lvl NC 3.3
  • Manufacturer
    Nobel Biocare

Manufacturer

Nobel Biocare