Events

Rappel de Triathlon Distal Capture Assembly

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-2015-RN-00140-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-24
  • 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-00140-1
  • 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 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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA