Events

Rappel de Global Cup Poly Liner, Neutral prostheses(part of the Global Cup Acetabular 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 Global Orthopaedic Technology 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-01262-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-22
  • 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-2017-RN-01262-1
  • 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
    Global orthopaedic has become aware that certain lots of the global cup poly liner, were manufactured with an internal diameter whose tolerance did not conform to iso 7206-2:2011.According to iso 7206-2, the spherical socket of global cup poly liner, shall have an internal diameter equal to the nominal diameter within a tolerance of +0.10mm to +0.30mm. the affected lots were manufactured with an internal diameter equal to the nominal diameter within a tolerance of +0.02mm to +0.07mm. whilst oversized relative to the nominal diameter of the femoral head, the internal diameters of the product have the potential to alter torque and/or wear rates when articulating against the femoral head, potentially leading to early mechanical loosening or loosening over time due to osteolysis.Post-market surveillance has not indicated any clinical or biomechanical evidence to suggest that they are associated with an increased risk of loosening, lysis or revision.
  • Action
    Global Orthopaedic is informing implanting surgeons to consider the provided information during follow up for relevant patients.

Device

Global Cup Poly Liner, Neutral prostheses(part of the Global Cup Acetabular System)
  • Modèle / numéro de série
    Global Cup Poly Liner, Neutral prostheses(part of the Global Cup Acetabular System)Part Number: GM09002-207-xxMultiple Products and Lot NumbersARTG Number: 218814
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd