Events

Alerta De Seguridad para AnspachR Single-use Cutting Burs and Irrigation Clips

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

¿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
    2011-10-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111004.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: synthes anspachr single-use cutting burs and irrigation clips medical device manufacturer, synthes, has issued a field safety notice concerning anspachr single-use cutting burs and irrigation clips used with anspachr electri and pneumatic high speed drill system. this removal is being conducted because anspachr has observed separation between the clear layers of the pouch during real time aging studies. as a result of the separation, it is possible to have a breach in the sterile barrier. this removal action is limited to product that is packaged in a tyvek pouch where the product is retained within a tube. products that are retained within a snap tray are not affected by this removal action. anspachr has not received any reports of incidents or adverse events related to this issue. according to the local supplier, affected products have been distributed in hk. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

AnspachR Single-use Cutting Burs and Irrigation Clips
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Anspach Single-use Cutting Burs and Irrigation Clips
  • Manufacturer
    Synthes

Manufacturer

Synthes