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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00574-1
Product Name/Description	Elements Motor and TF Adaptive Starter Kit (Dental motor used with endodontic rotary instruments) Elements Motor Part numbers: 815-1500 and 815-1502 TF Adaptive Starter Kit Part numbers: 815-1530, 815-1531 and 815-1532 ARTG number: 193033
Recall Action Level	Retail
Recall Action Classification	Class III
Recall Action Commencement Date	12/06/2013
Responsible Entity	Ormco Pty Ltd
Reason/Issue	Ormco is advising that the descriptor field of the file settings may become partially fragmented while in Standby mode. This does not change the performance of the device and the rpm/speed or ratio displays remain as depicted in the Instructions for Use (IFU).
Recall Action	Recall for Product Correction
Recall Action Instructions	Ormco are providing work around instructions, and will be providing a software update to permanently correct the issue.
Contact Information	1800 643 603 - Ormco Customer Care