Events

Rappel de Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty)

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-2016-RN-01315-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-13
  • 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-01315-1
  • 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 has identified an issue with the tha 3.1 and tha 3.1.1 software which may cause the surgeon to experience a feeling of vibration in the robotic arm during acetabular preparation. should vibration occur, the surgeon may need to reposition the arm during reaming of a planned cup position which may result in complications associated with extended surgery time of less than 15 minutes. the occurrence of this vibration will be corrected through the installation of an upgraded software version tha 3.1.1.1 on the mako system.
  • Action
    Stryker is advising users to inspect inventory for affected products. Users with affected product will be contacted by Stryker who will coordinate the installation of a software update as a permanent correction. In the interim, users can continue to use the affected product and mitigate the risk of vibration by following the instructions on the User Guide (PN 210555 – THA 3.1 Application User Guide, PN 212026 – THA 3.1.1 Application User Guide) and Surgical Technique (PN 210558 – THA 3.1 Surgical Technique, PN 212027 – THA 3.1.1 Surgical Technique) for proper pin placement/ securement, recommended Mako system setup and patient securement. This action has been closed-out on 18/05/2017.

Device

Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigat...
  • Modèle / numéro de série
    Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty)Item Numbers: 212212-01, 212212-03, 212212-99, 212212, 212103-01, 212103-03, 212103-99, 212103, 212110, 212100-01, 212100-03, 212100, 212220-01, 212220-03, 212220, 212042, 212034, 212239, 212240, 212243, 212244 (Kits that include software) ARTG Number: 223106
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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