Events

Retiro De Equipo (Recall) de Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)

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-00972-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-01
  • 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-00972-1
  • 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 a customer complaint which reported that during a total hip replacement the surgeon was using the exeter small tapered pin reamer when the device fractured approximately 3 inches from the tip. this may result in the tip of the reamer detaching from the instrument. should this occur and the fragment remain in situ, there are additional potential hazards including excessive metal ions and displacement from mri.
  • Acción
    Stryker is advising users to quarantine any affected stock for replacement.

Device

Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)
  • Modelo / Serial
    Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)Catalogue Numbers: 0932-0-000 (small) and 0932-2-000 (large)Lot Numbers (small): GW281208, GW284192, GW288907, GW282586, GW282310, GW298838, GX303720, GX302994 and GX301732 Lot Numbers (large): GW288908, GW282454 and GW288485ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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