Events

Retiro De Equipo (Recall) de Surgical instruments for traumatology and orthopedics, cutting and percussion with a sharp (cutting) edge with accessories

Según Federal Service for Surveillance in Healthcare, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Russian Federation que fue producido por Zimmer GmbH.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    01И-1594/18, РЗН 2016/3834
  • Fecha
    2018-06-25
  • Fecha de publicación del evento
    2018-06-26
  • País del evento
    Russian Federation
  • Fuente del evento
    FSSH
  • URL de la fuente del evento
    http://www.roszdravnadzor.ru/services/unreg
  • Notas / Alertas
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Notas adicionales en la data
    Manufacturer Recall

Device

Surgical instruments for traumatology and orthopedics, cutting and percussion with a sharp (cutti...

Manufacturer

Zimmer GmbH
  • 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
    FSSH