Events

Retiro De Equipo (Recall) de Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems)

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-2015-RN-01207-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-12-08
  • 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-2015-RN-01207-1
  • 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 become aware of the potential for confusion with regards to the intended use for the titanium fluted stem extender, based on the addition of the text "cemented use only" on the product label. the fixation method of the titanium fluted stem extenders is not restricted in australia, and can be used for cemented or cementless applications, even though the labelling states "cemented use only". as a result, there exists the potential for confusion in the operating theatre, resulting in complications associated with a surgery time of less than five minutes.
  • Acción
    Customers are advised to immediately check all stock areas and quarantine any affected item. A Stryker Representative will contact customers to arrange for all affected components to be removed from the facility and arrange for a replacement, as required.

Device

Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Impl...
  • Modelo / Serial
    Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems)Multiple Item Numbers and Lot Numbers affectedARTG Number: 242297
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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