Events

Rappel de STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement 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 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-01266-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-09-28
  • 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-01266-1
  • 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 during an internal review that some items of the star sterile instrument kit have been unintentionally shipped to australia without being ce marked. non-sterile instrument alternatives are available for the australian market. based on design review by stryker and the availability of the necessary ifu information, no hazards are to be expected.
  • Action
    Customers are advised to inspect the inventory and quarantine any affected stock immediately. A Stryker representative will coordinate the return of any affected product. This action has been closed-out on 11/05/2017.

Device

STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)
  • Modèle / numéro de série
    STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)Multiple instruments within the STAR Instruments KitItem Number: 100-0071Lot Numbers: 20320, 30332ARTG Number: 240015
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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