Events

Rappel de Tibial Alignment Guide – iAssist Knee System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Zimmer Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00482-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00482-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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