Events

Rappel de Thoracic Pedicle Feeler

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-2017-RN-01337-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-23
  • 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-2017-RN-01337-1
  • 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 determined that a laser marking machine used to create the distance markings on the tip of the thoracic pedicle feeler has settings higher than those intended. this change leads to an increased energy being directed onto the tip of the thoracic pedicle feeler, causing material degradation where the laser marks exist.There is the potential for the tip of the thoracic pedicle feeler to break during use. if this occurs within the patient, migration of the broken tip could result in soft tissue or peripheral nerve injury requiring surgical intervention.
  • Action
    Stryker is advising users to quarantine any affected product and contact their local Stryker representative to coordinate the return and replacement of affected product.

Device

Thoracic Pedicle Feeler
  • Modèle / numéro de série
    Thoracic Pedicle FeelerItem Number: 6002-350-000 (contained within tray 6001035000-T)Serial Number: 10910ARTG Number: 175054
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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