Events

Rappel de Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia 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-2016-RN-00910-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-08
  • 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-2016-RN-00910-1
  • 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
    Stryker has received complaints from customers about the device dissociating or breaking during use. an analysis indicated that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved by the supplier, potentially resulting in disassociation from the instrument. there is a risk that the handle components, including a dowel pin and a locking pin, may potentially disassociate and fall into the wound intraoperatively, necessitating retrieval. there have been no injuries reported as a result of this issue.
  • Action
    Stryker is advising users to inspect inventory and remove the affected devices from the procedure trays. The trays can continue to be used once the affected items have been removed. The affected devices can be returned to Stryker.

Device

Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)
  • Modèle / numéro de série
    Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)Item Number: 6541-4-808All Lot Numbers ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA