| TGA Action ID |
RC-2026-RN-00616-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
PALACOS R+G pro 40, 60, 80 CE EUR and PALACOS MV+G pro 40, 60, 80 CE EUR and COPAL G+C pro 40, 80 CE EUR
All batches |
| ARTG Number |
220925, 309121, 455545 |
| Unique Device Identifier (UDI) |
04260102136304, 04260102136335, 04260102136366, 04260102136397, See attached list in supporting information for full list of UDI |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There have been isolated cases of monomer liquid leaking from the pro system.
Assessments carried out to date have shown that the system can continue to be used as intended. However, if the product does leak, the system will need to be discarded and an alternate product used.
If the product leaks, it cannot be entirely ruled out that users may come into contact with monomer liquid whilst handling the product. In the event of eye contact, there is a risk of temporary irritation, redness, a burning sensation or other local symptoms, which may require medical attention.
Eye protection control information is already part of the PALACOS and COPAL pro safety data sheets. Nevertheless, Heraeus have decided to expand the safety precautions as an additional layer of protection in the Instructions for Use. |
| Instructions for Customers/Users |
Customers are to:
- Ensure that suitable eye protection is worn whenever the system is being operated, in accordance with the applicable health and safety regulations.
The updated recommendation will be included in the next revision of the Instructions for Use. Until this update is available, users are advised to follow the measures described in the Customer Letter.
The product can continue to be used as intended. There is no need to exchange or return the product. |
| Action Commencement Date |
18/08/2026 |
| Responsible Entity |
|
| Contact Information |
02 8422 6100 - Mark Oldfield, Heraeus Medical Australia |