Events

Retiro De Equipo (Recall) de Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mm

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-01616-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-12-13
  • 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-01616-1
  • 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
    A complaint has been received that on the box label, the country of manufacture ("made in usa") was incorrectly labelled as “made in switzerland” and was missing the ce mark as well as the european authorised representative (“ec rep”) address.
  • Acción
    Stryker is advising customers with affected stock to return them for replacement or credit.

Device

Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mm
  • Modelo / Serial
    Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mmItem Numbers: 203065161, 203065201, 203065251, 203065301, 203065351, 203065451, 203065501 Multiple Lot NumbersARTG Number: 242299
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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