Events

Rappel de Triathlon TS Tibial Augments Sizes 3 and 6

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-2018-RN-00162-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-26
  • 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-2018-RN-00162-1
  • 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 discovered that the product/lot combinations referenced above may contain the incorrect size implant from what is labelled on the box.The triathlon ts tibial augments are laser marked with lot and catalogue number. although the product packaging for the four lots may not match the product contained within, the laser marked details on the implant would increase the likelihood that the surgeon or surgical staff would recognise that the incorrect implant was contained in the package.The size 3 and 6 triathlon ts tibial augments are also visibly different in size. the tibial augment implant can be compared to the corresponding size tibial augment trial (item number: 5545t301 and 5546t601) which would alert a user to a size mismatch.
  • Action
    Stryker is advising users that patients implanted with the affected products should continue to be followed up as per the normal protocol established with their surgeons.

Device

Triathlon TS Tibial Augments Sizes 3 and 6
  • Modèle / numéro de série
    Triathlon TS Tibial Augments Sizes 3 and 6Item Number: 5545A3301, 5546A601Lot Numbers: ER9WA1AARTG Number: 242298(Stryker Australia Pty Ltd - Knee wedge)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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