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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00119-1
Product Name/Description	LiNA Xcise Laparoscopic Morcellator Reference No: MOR-1515, MOR-1515-1, MOR-1515-6 ARTG Numbers: 226906 & 180377
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/02/2015
Responsible Entity	GRC Surgical Pty Ltd
Reason/Issue	GRC Surgical Pty Ltd, following recent advice and review of the instructions for use (IFU) of this device by the Therapeutic Goods Administration (TGA), is issuing a product correction to replace the IFU previously supplied with his product. The previous IFU has been identified as not containing sufficient warnings to adequately ensure safe use of the device. Changes to update the IFU have been reviewed by the TGA, and are in response to a TGA safety advisory statement following advice by the Urogynaecological Devices Working Group on 4th August 2014 regarding the use of Laparoscopic power morcellators (https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014) .
Recall Action	Recall for Product Correction
Recall Action Instructions	GRC Surgical Pty Ltd is requesting all the users to quarantine the devices until the existing IFU's are removed from circulation and replaced with the updated IFU. This action has been closed-out on 20/04/2017.
Contact Information	1300 201 027 - GRC Surgical