Events

Alerta De Seguridad para rHead Radial Head and Uni-Elbow System

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

¿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
    2017-10-27
  • Fecha de publicación del evento
    2017-10-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171027a.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: stryker gmbh rhead radial head and uni-elbow system medical device manufacturer, stryker gmbh, has issued a medical device safety alert concerning its rhead radial head and uni-elbow system. according to the manufacturer, the result of a review of the currently available data of the stryker rhead radial head and uni-elbow system was found to be inconclusive to continue supporting the performance of the device. consequently, the manufacturer has decided to remove the product from the global markets. health care professionals that have patients using the stryker rhead radial head / uni-elbow prosthesis system should continue to follow up those patients in accordance with the routine standard of care. according to the local supplier, 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 27 october 2017.

Device

rHead Radial Head and Uni-Elbow System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Stryker GmbH rHead Radial Head and Uni-Elbow System
  • Manufacturer
    Stryker GmbH

Manufacturer

Stryker GmbH
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH