Events

Retiro De Equipo (Recall) de HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-2014-RN-00200-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-24
  • 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-2014-RN-00200-1
  • 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
    Integra neurosciences has recently identified, through an internal evaluation, a risk of damage to the package (external pouch) of the hintegra total ankle prosthesis tibial and talar components during shipping/handling. this damage might lead to a breakage of the sterility barrier of this external pouch, thus posing the risk of a potential patient infection. the risk for an adverse patient consequence has been determined to be not likely based on the manufacturer’s health hazard evaluation.
  • Acción
    Integra trained representatives will be performing an inspection of the affected components at the healthcare facility before each surgery by following a verified inspection process. This will assure that only products without damages external pouches are used in surgeries.

Device

HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)
  • Modelo / Serial
    HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)Multiple Catalogue Numbers affected All unexpired lotsARTG Number: 173960
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd