Events

Rappel de MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)

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-2015-RN-01008-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-20
  • 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-2015-RN-01008-1
  • 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
    Tornier is informing users of the known risk potentially associated with over-expansion of the small-sized mopyc stem (ptr-s7) that can result in its postoperative fatigue fracture.Although the operating technique emphasises the fact that stem expansion should only be performed when rotation instability is observed in the shaft, tornier noticed that the stems which were subject to fracture were over-expanded. tornier is providing users with a surgical technique addendum to emphasise this key point of the operating technique and to avoid unnecessary stem expansion that may be harmful for the patient.
  • Action
    Tornier is providing users with a Surgical Technique Addendum to include further information regarding the risks of over expansion. This action has been closed-out on 25/08/2016.

Device

MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)
  • Modèle / numéro de série
    MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)All batches manufactured since 2011ARTG Number: 94231
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd