Events

Rappel de TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew Surgical 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-00757-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-08
  • 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-00757-1
  • 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 manufacturer has identified a manufacturing error which results in the proximal lag screw being positioned incorrectly. in the event an incorrectly positioned proximal lag screw hole inhibits drilling and causes the user to hit the nail, the following issues could occur: the nail is removed and/or the procedure is delayed, the nail’s fatigue life is reduced, causing the nail to fail within a short period of time.
  • Action
    The affected customer has been requested to inspect their inventory and quarantine the affected stock. The local Smith & Nephew Surgical representative will contact the customer to arrange for the product to be returned.

Device

TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D
  • Modèle / numéro de série
    TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125DBatch Number: 14CM03676Model Number: 71675206ARTG Number: 104370
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd