Events

Rappel de 8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ormco 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-2013-RN-00775-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-07
  • 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-2013-RN-00775-1
  • 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
    Ormco have found that some screws in the affected lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
  • Action
    Customers are asked to return any of the affected stock remaining in the inventory. Ormco is advising users to continue with normal treatment if the 8 mm screw is believed to have already been placed or in treatment. When the screw is ready to be removed, physicians are requested to take special care and to not over-torque the screw on removal. For more details, please see http://www.tga.gov.au/safety/alerts-device-8mmvectorscrew-130809.htm .

Device

8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)
  • Modèle / numéro de série
    8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)8mm Vector TAS ScrewPart Number: 601-0021Lot Number: 112911Vector TAS Start Kit (10 patient)Part Number: 601-0010Lot Number: 112911 (8mm screws from within the kit)ARTG Number: 145039
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd