Events

Alerta De Seguridad para Abutment Retrieval Instrument and Kit

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
    2015-06-22
  • Fecha de publicación del evento
    2015-06-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150622b.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: abutment retrieval instrument and kit medical device manufacturer, nobel biocare, has issued a medical device safety alert concerning its abutment retrieval instrument [zirconia cc rp/wp] and kit [product numbers: 37882 and 37508; lot number: 96149]. the manufacturer received a complaint regarding the abutment retrieval instrument that the abutment / metal adapter could not be removed together with the retrieval instrument from the implant as intended due to the incorrect functional length of the shell. since the retrieval instrument was used to ease a procedure, the degree of seriousness of the health hazard was judged by the manufacturer as very low. besides, if the retrieval instrument did not work, a tweezers or other instrument could be used to remove the metal adapter. product recall is ongoing. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2015.

Device

Abutment Retrieval Instrument and Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abutment Retrieval Instrument and Kit
  • Manufacturer
    Nobel Biocare

Manufacturer

Nobel Biocare