Events

Retiro De Equipo (Recall) de Triathlon Tibial Alignment Ankle Camp Extramedullary (Referencing Instrument supplied with Triathlon Total Knee Arthroplasty procedure kit)

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-00699-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-07-10
  • 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-00699-1
  • 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 orthopaedics has received complaints associated with cracks or fracture of the triathlon tibial alignment ankle clamp. as a result, there exists the potential for complications associated with extended surgery time greater than thirty minutes to retrieve a replacement ankle clamp.
  • Acción
    Stryker is providing surgeons with work around instructions to implement if they are presented with a compromised Tibial Alignment Clamp during surgery.

Device

Triathlon Tibial Alignment Ankle Camp Extramedullary (Referencing Instrument supplied with Triath...
  • Modelo / Serial
    Triathlon Tibial Alignment Ankle Camp Extramedullary (Referencing Instrument supplied with Triathlon Total Knee Arthroplasty procedure kit)Catalogue Number: 65412609All lot numbersARTG No: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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