| TGA Action ID |
RC-2026-RN-00088-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Endodontic Hand Files (K-Files, K-Flex, Triple-Flex, Hedstrom, Reamers)
Multiple lot numbers, part numbers and descriptions |
| ARTG Number |
452846, 452888 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
A discrepancy was identified in the Instructions for Use (IFU) for Hand Files regarding the cleaning time. The IFU listed an incorrect ultrasonic cleaning time of 5 minutes instead of the correct 10 minutes.
To date, no adverse events related to this error have been reported.
This action has been undertaken prior to notification to the TGA. |
| Instructions for Customers/Users |
The Hand Files IFU has been updated with corrected cleaning instructions for devices manufactured from December 2025 onward. |
| Action Commencement Date |
6/02/2026 |
| Responsible Entity |
|
| Contact Information |
02 8870 3000 - Kerr Customer Care |