Events

Notificaciones De Seguridad De Campo acerca de Affixus Hip Fracture Nail

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 Biomet Orthopaedics.

¿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
    1364
  • Fecha
    2017-12-01
  • 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

Affixus Hip Fracture Nail
  • Modelo / Serial
    Catalog Number: 814309180 814309260 814309320 814309340 814309360 814309400 814309420 814309440 814309460 814311180 814311300 814311380 814311440 814311460 814313260 814313320 814409260 814409340 814409380 814409440 814411320 814411360 814411440 814509180 814509260 814509300 814509320 814509340 814509360 814509380 814509400 814509420 814509440 814511180 814511260 814511280 814511300 814511320 814511340 814511360 814511380 814511400 814511420 814511440 814513280 814513300 814513440 814513460 814609280 814609300 814609320 814609340 814609400 814609420 814609440 814611260 814611280 814611300 814611340 814611380 814611400 814611420 814611440 814611460 814613460 Batch Number: 398590, 507350, 595480, 788580, 893400, 398610, 512520, 666800, 788620, 893410, 406280, 535120, 669850, 788630, 893430, 437960, 535130, 701480, 788650, 893450, 438020, 535150, 701640, 858640, 893460, 438040, 535230, 701700, 858740, 893470, 459160, 535240, 701720, 858780, 893480, 459170, 535690, 701780, 858790, 893490, 459190, 555180, 701810, 858830, 893500, 459200, 555460, 701830, 858840, 935900, 459230, 555620, 701900, 858900, 935970, 459240, 555730, 701940, 858930, 936020, 459250, 555810, 702050, 858960, 936100, 459270, 581620, 702190, 858970, 936140, 459290, 581630, 702230, 862150, 942010, 480050, 581640, 737630, 862170, 942020, 480070, 581700, 737670, 892880, 942050, 480090, 581910, 760030, 892940, 942070, 480330, 581960, 760270, 892950, 972840, 507130, 581970, 788380, 892960, 972900, 507300, 582240, 788410, 892990, 973000, 507320, 582360, 788440, 893070, 507340, 582380, 788460, 893090,
  • Descripción del producto
    Inactive implantable medical devices
  • Manufacturer
    Biomet Orthopaedics

Manufacturer

Biomet Orthopaedics
  • 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