Events

Rappel de Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial Tray

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Exactech 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-01273-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-07
  • 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-01273-1
  • 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
    Exactech initiated a corrective action for the affected catalogue numbers due to a design incompatibility between the optetrak offset spine stiffener screw and the optetrak constrained condylar (cc) tibial insert when used in conjunction with an optetrak offset tibial tray. the optetrak offset spine stiffener screw is offered in a variety of sizes and is used as a secondary means to secure the optetrak constrained condylar (cc) tibial insert to the optetrak offset tibial tray. in all but one combination, the next size optetrak offset spine stiffener screw can be used without any anticipated adverse health consequences. exactech anticipates there may be a slight surgical delay while a larger screw is opened.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Exactech has provided users with an updated compatibility chart.

Device

Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when...
  • Modèle / numéro de série
    Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial TrayMultiple Catalogue Numbers and ProductsAll serial numbers affectedARTG Number: 252474
  • Manufacturer
    Exactech Australia Pty Ltd

Manufacturer

Exactech Australia Pty Ltd