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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00775-1
Product Name/Description	8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw) 8mm Vector TAS Screw Part Number: 601-0021 Lot Number: 112911 Vector TAS Start Kit (10 patient) Part Number: 601-0010 Lot Number: 112911 (8mm screws from within the kit) ARTG Number: 145039
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	7/08/2013
Responsible Entity	Ormco Pty Ltd
Reason/Issue	Ormco have found that some screws in the affected lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
Recall Action	Hazard Alert
Recall Action Instructions	Customers are asked to return any of the affected stock remaining in the inventory. Ormco is advising users to continue with normal treatment if the 8 mm screw is believed to have already been placed or in treatment. When the screw is ready to be removed, physicians are requested to take special care and to not over-torque the screw on removal. For more details, please see http://www.tga.gov.au/safety/alerts-device-8mmvectorscrew-130809.htm .
Contact Information	1800 643 603 - Ormco Pty Customer Care