Events

Rappel de Xia 3 Titanium Torque Wrench

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-00745-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-17
  • 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-00745-1
  • 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 reports that the hex tip of the listed torque wrenches have been fracturing during final tightening. the hex tip of the wrench has broken off and separated from the main tube.The manufacturer has identified four possible hazardous situations:· delay in surgery time (< 5 minutes) if an alternative torque wrench is needed· debris of non-implantable grade material falling into the wound· over/under-tightening of the blocker if an alternate instrument is not available· accidental implanting of the hex tip.
  • Action
    Customers are requested to quarantine all affected lots. A Stryker representative will contact all affected customers to arrange for collection of the affected products. Unaffected replacement units will be provided. This action has been closed-out 18/04/2017.

Device

Xia 3 Titanium Torque Wrench
  • Modèle / numéro de série
    Xia 3 Titanium Torque WrenchCatalogue Number: 48237028Lot Numbers: 098525, Xia 3 Torque Wrench ShortCatalogue Number: 482397028Lot Numbers: 11E035ARTG Number: 160151
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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