Events

Retiro De Equipo (Recall) de Trident Tritanium Acetabular Window Trials Case

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-2013-RN-01356-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-23
  • 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-2013-RN-01356-1
  • 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 that some outer trays of the trident tritanium acetabular window trials case have case handles which were installed upside-down, thus blocking 2 of the 4 slots that allow clips to secure the lid to the case. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips making the contents unsterile. note that the plastic tray insert and instrument contents of this tray are not affected by this issue and may continue to be used independently of the outer tray.
  • Acción
    Stryker is requesting their customers to inspect and quarantine any units from the affected lot. A Stryker representative will arrange for the return of any affected product.

Device

Trident Tritanium Acetabular Window Trials Case
  • Modelo / Serial
    Trident Tritanium Acetabular Window Trials CaseCatalogue Number: 24024020Lot Number: 032173ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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