Events

Retiro De Equipo (Recall) de Tibial Alignment Guide – iAssist Knee 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 Zimmer 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-00482-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-05
  • 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-00482-1
  • 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
    Based upon complaint investigation, zimmer cas has determined that the potential exists for the spikes on the iassist tibial alignment guide to bend or break during insertion or extraction from the tibia during use. the bending or breakage of the spikes is due to a stress riser at the junction of the spike and the main body of the instrument in combination with the presence of repeated high cyclic bending stresses from the impaction method utilized. these stresses are significantly increased when the proper steps of the surgical technique are not followed. although unlikely, if a spike breaks and goes unobserved, there is the possibility of a spike being left in the surgical site. there have not been any complaints for this instrument associated with a spike being left in a patient. product manufactured after may 2014 is not affected as they have a different assembly method of the spike that reduces the risk of fatigue.
  • Acción
    Zimmer is notifying hospitals and surgeons of this issuing and providing instructions on how to minimise the risk of bending or breaking. Further action will be carried out by Stryker pending the availability of replacement units. This action has been closed-out on 07/06/2016.

Device

Tibial Alignment Guide – iAssist Knee System
  • Modelo / Serial
    Tibial Alignment Guide – iAssist Knee SystemTibial Alignment Guide Part Number: 20-8011-013-00Lot Numbers: 120265, 120793, 120794, 130135, 130539ARTG Number: 205936
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA