Events

Rappel de Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System)

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 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-2016-RN-00980-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-22
  • 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-2016-RN-00980-1
  • 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
    Smith & nephew pty ltd is advising several lots of trigen internal hex captured recon screw blue 6.4mm x 65mm were supplied with incorrect instructions for use (ifu). the fracture fixation ifu (reference 81078017) was packaged with the device instead of the correct intramedullary nail system ifu (reference 81090283). affected products do not need to be returned. the affected products meet all other product specifications and can be used.
  • Action
    Smith & Nephew are providing users with the correct Instructions for Use (IFU). This action has been closed-out on 23/05/2017.

Device

Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as p...
  • Modèle / numéro de série
    Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System)Model Number: 71642365Batch Numbers: 12BM01456, 12FM15060, 12JM09146, 13AM18101, 13EM08756, 13GM11807, 13GM11808, 13GM18304, 13GM20483, 13GM20486, 13HM20836, 15CM19083, 15FM02129ARTG Number: 104369
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd