Events

Rappel de Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems)

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-01207-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-12-08
  • 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-2015-RN-01207-1
  • 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 of the potential for confusion with regards to the intended use for the titanium fluted stem extender, based on the addition of the text "cemented use only" on the product label. the fixation method of the titanium fluted stem extenders is not restricted in australia, and can be used for cemented or cementless applications, even though the labelling states "cemented use only". as a result, there exists the potential for confusion in the operating theatre, resulting in complications associated with a surgery time of less than five minutes.
  • Action
    Customers are advised to immediately check all stock areas and quarantine any affected item. A Stryker Representative will contact customers to arrange for all affected components to be removed from the facility and arrange for a replacement, as required.

Device

Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Impl...
  • Modèle / numéro de série
    Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems)Multiple Item Numbers and Lot Numbers affectedARTG Number: 242297
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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