Events

Retiro De Equipo (Recall) de Triathlon Distal Capture Assembly

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-2015-RN-00140-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-24
  • 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-2015-RN-00140-1
  • 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 regarding the disassociation of the cross pin from the action triggers of the triathlon distal capture assembly, which could lead to a loose or disassociated action trigger mechanism and/or loose or disassociated cross pin. although using a capture for the distal femoral resection or proximal tibial resection in a triathlon primary total knee arthroplasty is optional, if the surgeon elects to utilize a capture and such disassociation occurs, there exists the potential for the following harms:·complications associated with a delay in surgery of =15 minutes;·revision surgery to retrieve loose component(s);·local inflammatory response;·inflammatory response stryker representatives will contact customers to physically inspect and remove affected units in the field.
  • Acción
    A Stryker representative will arrange for all non-conforming components to be removed and a replacement arranged as required. In the event a Stryker Representative is not available to visit your location to perform the inspection, detailed inspection instructions are provided via the Customer Letter. This action has been closed-out on 21/04/2017.

Device

Triathlon Distal Capture Assembly
  • Modelo / Serial
    Triathlon Distal Capture AssemblyCatalogue Number: 65411723 All lotsInstrument trays that contain the affected device: 65418002-T & SHAPECONV-TARTG number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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