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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00111-1
Product Name/Description	Endobon Xenograft Granules ROX05 Endobon-Xenograft Granules 0.5 ml ROX10 Endobon-Xenograft Granules 1 ml ROX20 Endobon-Xenograft Granules 2 ml ROXLG20 Endobon-Xenograft Granules 2 ml ROXLG50 Endobon-Xenograft Granules 5 ml ROXLG80 Endobon-Xenograft Granules 8 ml Multiple Batch Numbers affected ARTG Number: 171507
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	28/01/2016
Responsible Entity	Biomet 3i Australia Pty Ltd
Reason/Issue	Biomet has initiated this action based on results which indicated cytotoxicity tests were not passed at 36 months (real-time) ageing (grade 4 toxicity). If the affected product is used, there is a remote probability that the patient may experience soft tissue irritation and infection.
Recall Action	Recall
Recall Action Instructions	Biomet 3i is advising users to inspect stock and quarantine the affected units prior to their return. Biomet 3i will replace the affected units.
Contact Information	1800 802 457 - Biomet 3i