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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01005-1
Product Name/Description	nanOss Bioactive 10cc Bone Void Filler Catalogue Number: 90-100-10E Lot Number: 257592 Expiry: 10/03/2018 ARTG Number: 279230
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	10/08/2017
Responsible Entity	RTI Surgical Australia Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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. This has been closed out on the 24/09/2018.
Contact Information	02 6108 3062 - RTI Surgical