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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00473-1
Product Name/Description	Medtronic Navigated Cannulated Taps Multiple model numbers affected ARTG Number: 120114, 126291
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/06/2015
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Cannulated taps have the potential to accumulate bone and other tissues in the cannula. Use without a guide wire can increase this possibility. Medtronic has received reports of user injuries occurring during the cleaning process of cannulated taps that have bone material in the cannula of the devices.
Recall Action	Recall for Product Correction
Recall Action Instructions	Medtronic is modifying the instructions for use for the cannulated taps to clearly detail the potential for bone/tissue accumulation in the cannula of the devices if they are used without a guide wire and to caution the user during the cleaning process. If the obstruction in the cannula cannot be removed, the instructions for use indicate that the devices should be considered at the end of their useful life and should be discarded in accordance with your facility procedures and guidelines. The revised instructions for use are provided with the customer letter. This action has been clsoed-out on 24/08/2016.
Contact Information	02 9857 9179 - Medtronic Australasia Pty Ltd