Events

Retiro De Equipo (Recall) de Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)

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-00934-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-14
  • 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-00934-1
  • 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 product complaints stating that a rivet or rivets came off an exeter non v40 rasp handle. these complaints are associated with the exeter rasp handles with either the green or black plastic lever, manufactured between january 1995 and october 2005. the current exeter v40 rasp handles with a metallic lever are not within the scope of this recall. in the event that a rivet comes off the exeter non v40 rasp handle during surgery there are several hazards that would increase surgical time. these include locating the fragment, retrieving a sterilised replacement rasp handle and potentially an intra-operative x-ray if required. the exeter non v40 rasp handle may continue to function without the rivet.
  • Acción
    Stryker is advising users to inspect inventory and quarantine and remaining units of the affected product for return. This action has been closed out on 15 June 2017.

Device

Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter fem...
  • Modelo / Serial
    Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)Product Code: 0930-9-003All lots manufactured between January 1995 and October 2005ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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