Events

Rappel de Aequalis Ascend Flex Shoulder System PTC Humeral Stems

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-2017-RN-00860-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-14
  • 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-2017-RN-00860-1
  • 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
    Wright medical has identified a deviation of the manufacturing method for one lot of aequalis ascend flex shoulder system ptc humeral stems. this is a documentary discrepancy with regulatory impacts, but for which the patient risk was assessed as negligible.The subcontractor (who have manufactured the affected parts), used in fact the manufacturing method validated for tornier sas internal manufacturing, whereas the justification for the authorisation to use this method by the subcontractor, was insufficiently documented.
  • Action
    Measures to be taken by the customer: Wright Medical are asking that if any product is with customers, that they: 1. Locate and return parts; 2. Circulate this information to whom it may concern in the hospital; and 3. Inform a Tornier Representative of any adverse event.

Device

Aequalis Ascend Flex Shoulder System PTC Humeral Stems
  • Modèle / numéro de série
    Aequalis Ascend Flex Shoulder System PTC Humeral StemsReference Number: DWF602CLot Number: AA2028ARTG Number: 234030
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd