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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00982-1
Product Name/Description	Osseotite NT Certain Implant 5mm x 10mm (endosseous dental implant) Model Number: INT510 Lot/batch number: 2011090751 ARTG Number: 100482
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	25/09/2012
Responsible Entity	Biomet 3i Australia Pty Ltd
Reason/Issue	It has been identified that a very small percentage of implants may be missing the internal threading. The condition, if present, will prevent the cover screw, temporary healing abutment, final restorative abutment etc from assembling properly with the implant. This recall action was not notified to the TGA before it was initiated by Biomet 3i Australia.
Recall Action	Recall
Recall Action Instructions	Quarantine and return affected implants to Biomet 3i.
Contact Information	02 9855 4444 - Biomet 3i