Events

Retiro De Equipo (Recall) de STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement 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-01266-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-09-28
  • 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-01266-1
  • 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 during an internal review that some items of the star sterile instrument kit have been unintentionally shipped to australia without being ce marked. non-sterile instrument alternatives are available for the australian market. based on design review by stryker and the availability of the necessary ifu information, no hazards are to be expected.
  • Acción
    Customers are advised to inspect the inventory and quarantine any affected stock immediately. A Stryker representative will coordinate the return of any affected product. This action has been closed-out on 11/05/2017.

Device

STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)
  • Modelo / Serial
    STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)Multiple instruments within the STAR Instruments KitItem Number: 100-0071Lot Numbers: 20320, 30332ARTG Number: 240015
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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