Events

Notificaciones De Seguridad De Campo acerca de Java Posterior stabilization System,

Según Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Czechia que fue producido por Zimmer Spine SAS.

¿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
    Field Safety Notice
  • ID del evento
    816
  • Fecha
    2016-11-01
  • País del evento
    Czechia
  • Fuente del evento
    MHSIDCCCDMIS
  • URL de la fuente del evento
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notas / Alertas
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Notas adicionales en la data

Device

Java Posterior stabilization System,
  • Modelo / Serial
    Model Number: SN2023-1-00401 SN2023-1-00411 SN2023-1-00500 SN2023-1-00501 SN2023-1-00505 SN2023-1-00506 SN2023-1-00510 SN2023-1-00512 SN2023-1-00520 SN2023-1-00530 SN2023-1-00531 SN2023-1-00540 SN2023-1-00541 SN2023-1-00550 SN2023-1-00551 SN2023-1-00554 SN2023-1-00590 SN2023-1-00591 SN2023-1-00600 SN2023-1-00610 SN2023-1-00620 SN2023-1-00705 SN2023-1-00706 SN2023-1-00707 SN2023-1-00708 SN2023-1-00715 SN2023-1-00716 SN2023-1-00750 SN2023-1-00755 SN2023-1-00931 SN2023-2-00006 SN2023-2-00010 SN2036-1-00400 SN2036-1-00401 SN2036-2-00006 SN23-100400 SN23-100401 SN23-100410 SN23-100411 SN23-100500 SN23-100501 SN23-100510 SN23-100512 SN23-100515 SN23-100516 SN23-100520 SN23-100530 SN2023-1-00400 SN2023-1-00401 SN2023-1-00411 SN2023-1-00500 SN2023-1-00501 SN2023-1-00505 SN2023-1-00506 SN2023-1-00510 SN2023-1-00512 SN2023-1-00520 SN2023-1-00530 SN2023-1-00531 SN2023-1-00540 SN2023-1-00541 SN2023-1-00550 SN2023-1-00551 SN2023-1-00554 SN2023-1-00590 SN2023-1-00591 SN2023-1-00600 SN2023-1-00610 SN2023-1-00620 SN2023-1-00705 SN2023-1-00706 SN2023-1-00707 SN2023-1-00708 SN2023-1-00715 SN2023-1-00716 SN2023-1-00750 SN2023-1-00755 SN2023-1-00931 SN2023-2-00006 SN2023-2-00010 SN2036-1-00400 SN2036-1-00401 SN2036-2-00006 SN23-100400 SN23-100401 SN23-100410 SN23-100411 SN23-100500 SN23-100501 SN23-100510 SN23-100512 SN23-100515 SN23-100516 SN23-100520 SN23-100530 Batch Number: Všechny šarže
  • Descripción del producto
    Inactive implantable medical devices
  • Manufacturer
    Zimmer Spine SAS

Manufacturer

Zimmer Spine SAS
  • 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
    MHSIDCCCDMIS