Events

Rappel de SMR Glenosphere Impactor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Lima Orthopaedics 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-00578-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-06
  • 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-00578-1
  • 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
    Lima orthopaedics has received complains about the intra-operative breakage of the glenosphere impactors/extractors.The breakage occurs at a location corresponding to the threaded section which is screwed into the glenosphere before impacting the glenosphere into the metal back glenoid through the connector.If the reported issue occurs during surgery, it may result in a slight prolongation of the surgical time. although unlikely, in a worst case scenario, the surgeon would be unable to remove the broken thread from the glenosphere cavity nor be able to remove and replace the glenosphere, therefore the broken tip would remain in the patient.
  • Action
    Customers are advised to inspect stocks and quarantine the affected units prior to their return. This action has been closed out on 20/01/2017.

Device

SMR Glenosphere Impactor
  • Modèle / numéro de série
    SMR Glenosphere ImpactorProduct Code: 9013.74.141Lot Numbers: 1390763, 14AA094, 14AA528, 15AA557ARTG Number: 176877
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd