Events

Rappel de nanOss Bioactive 10cc Bone Void Filler

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par RTI Surgical 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-01005-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-08-10
  • 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-2017-RN-01005-1
  • 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
    Rti surgical has been advised that a specific batch of nanoss bioactive 10cc bone void filler was shipped at the incorrect revision.Although the revision of the product as a whole (implant, accessories, packaging, labelling) was rev a instead of rev b, the implant itself remained unchanged and is safe. the changes included removal of an accessory syringe provided for rehydration, and minor changes to the labelling and ifu. no changes between revisions impact patient safety.To date, there have been zero complaints, as this issue was found internally only.
  • Action
    RTI Surgical is requesting customers inspect their stocks and quarantine all units from the affected batch number. Complete the supplied Customer Acknowledgement Form and return it via email to RTI Surgical so that they may arrange for your stock to be recovered and for replacement stock, or a credit note to be issued. Complete the supplied Customer Acknowledgement Form even if you have no stock which is subject to this recall action as RTI Surgical requires this information to reconcile this process.

Device

nanOss Bioactive 10cc Bone Void Filler
  • Modèle / numéro de série
    nanOss Bioactive 10cc Bone Void FillerCatalogue Number: 90-100-10ELot Number: 257592Expiry: 10/03/2018ARTG Number: 279230
  • Manufacturer
    RTI Surgical Australia Pty Ltd

Manufacturer

RTI Surgical Australia Pty Ltd
  • Source
    DHTGA