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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00046-1
Product Name/Description	CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator Catalogue Numbers: C6623, C6636 All lot numbers affected ARTG Number: 197945
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/01/2013
Responsible Entity	Integra Neurosciences Pty Ltd
Reason/Issue	Integra Neurosciences has been notified by the manufacturer that since 2009 they have received a small number of complaints for CUSA tip breakage. The manufacturer's investigation of these complaints identified that when the tips are used under specific circumstances with the CEM Nosecone, there is the potential for erosion of the CUSA tip. The erosion can potentially lead to tip breakage. Specifically, the potential for CUSA tip erosion occurs only during CEM operation and if the side of the tip, rather than the annulus of the tip, is in contact with the tissue.
Recall Action	Recall for Product Correction
Recall Action Instructions	Integra Neurosciences Pty Ltd is revising the package insert to include an additional warning advising users to ensure that only the CEM Nosecone contacts the intended tissue at the annulus of the tip and not the side of the tip to avoid tip breakage.
Contact Information	1300 550 599 - Integra Customer Service