| TGA Action ID |
RC-2026-RN-00829-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SCORE tibial base plate
Cemented - Size 4
Lot Number: 432996 |
| ARTG Number |
210578 |
| Unique Device Identifier (UDI) |
0370108950 9305 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The size information engraved on the implant indicates a size 3 while the device is a size 4.
The labelling of the device consisting of an external label as well as traceability labels is compliant and indicates a size 4. |
| Instructions for Customers/Users |
For devices that have already implanted, no special patient follow-up is recommended. |
| Action Commencement Date |
19/10/2026 |
| Responsible Entity |
|
| Contact Information |
08 8297 9901 - Amplitude Customer Service |