Events

Recall of nanOss Bioactive 10cc Bone Void Filler

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by RTI Surgical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01005-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01005-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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