Events

Retiro De Equipo (Recall) de Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia 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-00910-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-08
  • 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-00910-1
  • 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
    Stryker has received complaints from customers about the device dissociating or breaking during use. an analysis indicated that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved by the supplier, potentially resulting in disassociation from the instrument. there is a risk that the handle components, including a dowel pin and a locking pin, may potentially disassociate and fall into the wound intraoperatively, necessitating retrieval. there have been no injuries reported as a result of this issue.
  • Acción
    Stryker is advising users to inspect inventory and remove the affected devices from the procedure trays. The trays can continue to be used once the affected items have been removed. The affected devices can be returned to Stryker.

Device

Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)
  • Modelo / Serial
    Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)Item Number: 6541-4-808All Lot Numbers ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA