Events

Rappel de Trident Tritanium Acetabular Window Trials Case

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-2013-RN-01356-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-23
  • 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-2013-RN-01356-1
  • 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 become aware that some outer trays of the trident tritanium acetabular window trials case have case handles which were installed upside-down, thus blocking 2 of the 4 slots that allow clips to secure the lid to the case. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips making the contents unsterile. note that the plastic tray insert and instrument contents of this tray are not affected by this issue and may continue to be used independently of the outer tray.
  • Action
    Stryker is requesting their customers to inspect and quarantine any units from the affected lot. A Stryker representative will arrange for the return of any affected product.

Device

Trident Tritanium Acetabular Window Trials Case
  • Modèle / numéro de série
    Trident Tritanium Acetabular Window Trials CaseCatalogue Number: 24024020Lot Number: 032173ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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