Events

Alerta De Seguridad para A2FN Reamer

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
    2011-11-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111101.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
    Product recall: synthes a2fn reamer medical device manufacturer, synthes, is initiating a recall for the a2fn reamer (part number: 03.010.368) due to the potential for the drill stop to slip on the reamer. according to the manufacturer, if the drill stop slips on the reamer, it may cause deeper reaming than intended and in very rare cases, penetration of joint space causing pain and / or joint irritation. synthes urged users ceasing use of the affected products. the manufacturer has already changed the design of the a2fn reamer. the new designed reamers are available to replace. according to local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact synthes for necessary actions.

Device

A2FN Reamer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes A2FN Reamer
  • Manufacturer
    Synthes

Manufacturer

Synthes