Events

Rappel de TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)

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-2013-RN-01048-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-10
  • 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-2013-RN-01048-1
  • 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
    Two batches of silicone potting have been identified by the supplier as having cure properties that were outside of the specified range. the potting material is used to insulate, stabilise and provide a moisture barrier to the main printed circuit board assembly (pcba) of the tps microdriver. inadequate curing of the silicone potting creates the possibility for silicone potting to leak outside of the handpiece and cause electrical malfunction.
  • Action
    Stryker is requesting users to inspect and quarantine devices from the affected lot numbers. Affected devices are to be returned to Stryker for repair before returning to the customers. Stryker will provide a loan unit to be used until the device is repaired.

Device

TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins,...
  • Modèle / numéro de série
    TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)Catalogue Number: 5100088000Lot Numbers: 0921700523, 0723606673ARTG Number: 139725
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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