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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 .
Contact Information 1800 643 603 - Ormco Pty Customer Care