Events

Rappel de Guide Wires and K-Wires for T2 and Gamma Nailing 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-2016-RN-00002-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-04
  • 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-00002-2
  • 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
    It has been discovered that the seal integrity of the pouch may be decreased. a potential capillary defect in the sealing could potentially lead to the product becoming unsterile, which could result in an infection. no injury or harm has been reported for this event so far.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Guide Wires and K-Wires for T2 and Gamma Nailing Systems
  • Modèle / numéro de série
    Guide Wires and K-Wires for T2 and Gamma Nailing SystemsCatalogue numbers: 01520218S,12106450,18060050S,18060080S,18060083S,18060084S, 18060085S, 18060090S, 18060093S, 18061250S, 18061417S, 18063030S, 18063031SMultiple Lot Numbers affectedARTG Number: 190236
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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