Events

Retiro De Equipo (Recall) de Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set)

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-01246-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-22
  • 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-01246-1
  • 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 the trays of the affected lot number are missing two of the four necessary cut outs. these cut outs provide clearance to secure the clips on the tray lid to the base. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips, making the contents of the tray unsterile. a potential tear would likely be noticed by the surgical staff before the instrument is used as the blue wrap is checked for any defects prior to surgery.
  • Acción
    Stryker is advising users to remove any affected trays from use. Any affected trays will the replaced by Stryker.

Device

Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation...
  • Modelo / Serial
    Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set)Catalogue Number: 62789970Lot Number: 039980ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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