Events

Notificaciones De Seguridad De Campo acerca de Zimmer othopedic surgical instruments

Según Agency for Medical Products and Medical Devices of Croatia, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Croatia que fue producido por Zimmer.

¿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
    2014_zimmer_gmbh_switzerland_manual_for_orthopedic_surgical_instruments_instructions_for_care_cleaning_maintenance_and_sterilisation_of_zimmer_instruments_1002
  • Fecha
    2014-01-23
  • País del evento
    Croatia
  • Fuente del evento
    AMPMDC
  • URL de la fuente del evento
    http://www.halmed.hr/en/Medicinski-proizvodi/Sigurnosne-informacije/Sigurnosne-obavijesti-o-medicinskim-proizvodima/2014/Zimmer-GmbH-Switzerland-Manual-for-orthopedic-surgical-instruments-Instructions-for-care-cleaning-maintenance-and-sterilisation-of-Zimmer-instruments-/1002
  • Notas / Alertas
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Notas adicionales en la data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Zimmer, GmbH on the change in cleaning and sanitation of Zimmer othopedic surgical instruments.
    The manufacturer has amended Instructions for care, maintenance and sterilisation of Zimmer instruments in chapters 8F, 8I and 11 of the Manual for orthopaedic surgical instruments.
    Here you may view the safety information addressed to users.

Device

Zimmer othopedic surgical instruments
  • Modelo / Serial
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • 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
    AMPMDC