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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01300-1
Product Name/Description	CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator Catalogue Numbers: C6623 and C6636 Lot Numbers: All lots ARTG Number: 197945
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/12/2013
Responsible Entity	Integra Neurosciences Pty Ltd
Reason/Issue	Integra Neurosciences has been notified by the manufacturer that there may be the potential that the blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position. A small number of complaints where this has occurred have been reported and of those, a smaller number resulted in tissue burn.
Recall Action	Recall for Product Correction
Recall Action Instructions	Integra is providing an Update to the Instructions for Use (IFU). Integra is advising users to replace nosecone if the COAG button is observed to be sticking and contact Integra. Integra is advising users to check the nosecone during setup and prior to patient use and replace nosecone if observed to be sticking. If the Nosecone is to be used in excess of approximately 30 minutes during surgery, Integra is advising to replace the nosecone after 30 minutes of activation.
Contact Information	1300 550 599 - Integra Customer Service