Events

Rappel de Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation of SMR anatomic and Reverse shoulder prosthesis)

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-01053-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-10
  • 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-01053-1
  • 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
    The manufacturer, limacorporate has received two complaints about the allen wrench. firstly, the impossibility to connect the allen wrench to the t-handle intra-operatively. secondly, after a difficult insertion, it was impossible to remove the allen wrench from the t-handle. in both cases, there were no reported consequences for the patients. limacorporate's investigations have shown that the diameter of the zimmer connection on the allen wrench has been manufactured out of specification and is over-dimensioned. this leads to difficult/impossible coupling between the allen wrench and the t-handles.
  • Action
    Lima Orthopaedics' kit coordinator will be visiting hospitals and replacing affected devices in the SMR instrument sets with unaffected devices. This action has been closed-out on 20/02/2017.

Device

Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation ...
  • Modèle / numéro de série
    Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation of SMR anatomic and Reverse shoulder prosthesis)Allen Wrench 5mmProduct Code: 9013.50.210Lot Number: 14AA311 SMR instrument setProduct Codes: 9013.23.000, 9013.43.000, 9013.45.000ARTG Number: 176592
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd