Events

Rappel de Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes 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-2014-RN-00354-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-24
  • 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-2014-RN-00354-1
  • 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
    The product for this particular lot (3632704) was distributed with "not for human use" etched on the side of the tool. the etching was intended to indicate that the devices were for training purposes only. if the "not for human use" etching on the threaded reduction tool is discovered prior to its use on the patient, but in the operative theatre, it could lead to a small surgical delay until a replacement product is procured.Synthes has advised that if the product was used in an operation, the threaded reduction tool would work as intended and the patient would not be exposed to any increased risk.
  • Action
    End users are requested to immediately isolate any devices from the affected lot. Affected devices are to be returned to Synthes Australia.

Device

Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling
  • Modèle / numéro de série
    Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal couplingPart Number: 03.507.002SLot Number: 3632704ARTG Number: 155807
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd