Events

Rappel de Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Tornier 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-00971-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-18
  • 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-00971-1
  • 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
    Complaints have been received which describe a non-optimum grip of tibial inserts with the tibial impactor salto talaris which could lead to the fall of the implant. tornier's investigations have led to the conclusion that only sizes 0 and 1 of the tibial implant are not sufficiently maintained by the tibial impactor which, however, remains functional.
  • Action
    Tornier advised their customers that even if the impactor does not ensure optimal holding of sizes 0 and 1 only of the tibial implant, it can still safely be usedand requested that care be taken when using the device for implantation of sizes 0 and 1 of the tibial implants. Tornier is redesigning the device and will notify customers once complete.

Device

Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talar...
  • Modèle / numéro de série
    Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)Serial Numbers: 30, 152ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd