Events

Rappel de Omega+ Lag Screw Ø13X110MM ST

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia 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-00526-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-28
  • 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-00526-1
  • 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
    Stryker gmbh has received a customer complaint that the lag screw would not completely cannulate as the guide wire would not pass through the cannula of the screw. no harm was reported. it was found on investigation that the obstruction is related to a metal burr in the cannula of the screw which was not removed during manufacturing causing obstruction. the obstruction in the cannula of the screw is easily recognisable for the user. in most cases the surgeon would detect significant resistance when passing the lag screw over the guide wire before it touches the skin and would not continue using the screw. a different screw would be available and used, resulting in a minor delay in surgery of <15 minutes. if the surgeon does not notice or ignores the resistance, then surgical complications related to the guide wire being stuck in the cannulated screw and/or the guide wire being pushed out of the femoral head could theoretically occur.
  • Action
    Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate the return and replacement of the product.

Device

Omega+ Lag Screw Ø13X110MM ST
  • Modèle / numéro de série
    Omega+ Lag Screw Ø13X110MM STItem Number: 33625110Lot Number: V06279Ø13X105MM STItem Number: 33625105Lot Number: V06269ARTG Number: 119660
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA