| TGA Action ID |
RC-2026-RN-00354-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Medartis 5.0 Headed CCS Long thread, 50mm
Part Number: A-8216.50
Lot Numbers: 24425542, 24404471, 25444702 |
| ARTG Number |
206157 |
| Unique Device Identifier (UDI) |
07630037887706 |
| Action Type |
Recall / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Cannulation of this screw has been identified during routine screw inspections to be not centred.
This market action does not affect any other lots or batches of 5.0 Headed CCS screws or any other Medartis products.
To date, no reports have been received globally from customers. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock immediately and quarantine affected lot number on hand to prevent further use.
- Return affected stock on hand.
Implanted stock
- It is recommended that, during the routine follow up visits before the physiological bone healing has taken place, the patient is specifically asked about any symptoms that could indicate implant failure. If these symptoms are confirmed, please contact Medartis.
- A more conservative progression of weightbearing is advised, particularly in high risk patients.
This action has been closed out on 12/10/2026 |
| Action Commencement Date |
14/05/2026 |
| Responsible Entity |
|
| Contact Information |
0451 860 638 - Aoife O Callaghan, Medartis Australia |