Events

Rappel de Spectra System/Legacy Guided Surgery Handle Kit Inserts

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Implant Direct Oceania 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-01423-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-20
  • 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-01423-1
  • 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
    Implant direct oceania pty ltd is informing users of a recall of four (4) lots of spectra system/legacy guided surgery handle kit/inserts due to receiving 3 complaints on these products. through the reporting process, implant direct have found that the g-hk guided surgery handle inserts may be out of implant direct specification. the 3.4mm guide insert will not allow the 3.4 drill to pass through, since the diameter is too small. in addition, the 2.3mm guide may be too large for the drill. these discrepancies may lead to the possibility of a delay in procedure for the patient if the drilling sequence is discontinued or the clinician would need to continue the surgical procedure without the use of the drill guide. there have been no injuries as a result of this issue.
  • Action
    Implant Direct is advising users to inspect stock and return affected units.

Device

Spectra System/Legacy Guided Surgery Handle Kit Inserts
  • Modèle / numéro de série
    Spectra System/Legacy Guided Surgery Handle Kit InsertsPart Numbers: G-HKKit Lot Numbers: 42562, 52987, 64245 and 74772ARTG Number: 296286
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA