Retiro De Equipo (Recall) de Triathlon MIS Modular Distal Capture (optional tool which can be attached to the distal resection guide to complete the cut)

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 customer complaints regarding the triathlon mis modular distal capture device disassociating during use. this may result in one or more of the following potential patient harms: · complications associated with extended surgery time· inflammation / inflammatory response.· revision surgery to retrieve loose spring.
  • Acción
    Stryker is advising users to inspect stock and quarantine any affected units. Affected units will be replaced with unaffected stock. This action has beem closed-out on 05/12/2016.


  • Modelo / Serial
    Triathlon MIS Modular Distal Capture (optional tool which can be attached to the distal resection guide to complete the cut)Part Number: 6541-5-723Lot Numbers: AF1C11, AF1C11M, AF1E01D, AF1E01MX3, AF1T43, AF8V03ARTG Number: 140892
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source