Events

Rappel de Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)

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-00972-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-01
  • 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-00972-1
  • 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 a customer complaint which reported that during a total hip replacement the surgeon was using the exeter small tapered pin reamer when the device fractured approximately 3 inches from the tip. this may result in the tip of the reamer detaching from the instrument. should this occur and the fragment remain in situ, there are additional potential hazards including excessive metal ions and displacement from mri.
  • Action
    Stryker is advising users to quarantine any affected stock for replacement.

Device

Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)
  • Modèle / numéro de série
    Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)Catalogue Numbers: 0932-0-000 (small) and 0932-2-000 (large)Lot Numbers (small): GW281208, GW284192, GW288907, GW282586, GW282310, GW298838, GX303720, GX302994 and GX301732 Lot Numbers (large): GW288908, GW282454 and GW288485ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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