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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