Events

Alerta De Seguridad O Notificaciones De Seguridad para Zimmer Biomet, specific hip and trauma instruments

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Zimmer GmbH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2018-02-15
  • Fecha de publicación del evento
    2018-02-15
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/zimmer-biomet-specific-hip-and-trauma-instruments-risk-of-infection
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Manufactured by zimmer gmbh – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions (mda/2018/007).
  • Acción
    Quarantine affected devices and obtain replacements from the manufacturer. Refer to the manufacturer’s Field Safety Notice (ref ZFA2017-332) for a full list of affected devices. Report all adverse events involving these devices to Zimmer Biomet and the MHRA or the appropriate Devolved Administration.

Device

Zimmer Biomet, specific hip and trauma instruments

Manufacturer

Zimmer GmbH
  • Dirección del fabricante
    Anne-Catherine Morancy Meister Zimmer GmbH Sulzer Allee 8 Winterthur 8404 Switzerland Tel: +41 58 854 82 37
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    MHRA