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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