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 |
|
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 |