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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00052-1
Product Name/Description Integra Mayfield Ultra 360 Base Unit

Catalogue Number: A-2009

All Lot Numbers affected

ARTG Number: 170097
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 20/01/2015
Responsible Entity Integra Neurosciences Pty Ltd
Reason/Issue Mayfield Ultra 360 Base Units may experience a failure of the locking system during use due to the excessive clearance between the inner diameter (bore) of the cam rod and the mating post that may potentially result in adverse patient health consequence in the event a breakage occurs during Neurosurgical use.

No complaint reports have been received in Australia or New Zealand.
Recall Action Recall for Product Correction
Recall Action Instructions Customers are to be alerted to this issue and are advised to discontinue use of the device until lntegra verifies their device does not have excessive clearance or if it does, the excessive clearance is corrected. This action has been closed-out on 19/08/2016.
Contact Information 1300 550 599 - Integra Customer Service