Print version of this report

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