Events

Retiro De Equipo (Recall) de Kasios TCP and KagesKasios TCP, Kage, RSF, Wedge Kage, TLIF Kage RSF

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare Pty Ltd.

¿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
    RC-2016-RN-01443-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01443-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    An issue has been identified during the validation verification of the sterilisation procedures. there is a risk in connection to sterilisation conformity for specific batches. this could lead to an increased risk of infection in the days following surgery. no adverse event has been reported worldwide in relation to this issue.
  • Acción
    Life Healthcare is advising surgeons to review their patients who have been implanted with the affected products for any post-operative infection.

Device

Kasios TCP and KagesKasios TCP, Kage, RSF, Wedge Kage, TLIF Kage RSF
  • Modelo / Serial
    Kasios TCP and KagesKasios TCP, Kage, RSF, Wedge Kage, TLIF Kage RSFMultiple Item and Lot NumbersARTG Numbers: 192697, 186610, 141918, 178660
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd