| TGA Action ID |
RC-2026-RN-00509-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Southern Implants Multi-Unit abutment
Item Code: MC-SP-30D-2.5
Lot Number: 303V05D1 and 300V05D1
GMDN: 44879
Expiry Date: 16/02/2036 |
| ARTG Number |
450726 |
| Unique Device Identifier (UDI) |
06009544042693 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
There is a low probability that affected units labelled MC-SP-30D-2.5 may in fact be MC-SP-17D-1.5, meaning the collar height may be 1 mm shorter and the angulation lower than indicated on the label. This discrepancy remains unconfirmed for the distributed Australian units pending return and inspection of product.
The problem may result in product misidentification or unintended component selection. No complaints have been received in Australia, and no event involving death, serious deterioration in health, or recurrence likely to lead to such an outcome has been identified. The risk associated with using a potentially mislabelled abutment is low. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock and quarantine any units with lot number 303V05D1 or 300V05D1 to prevent further use.
- Return stock on hand with the completed response form to the sponsor.
- If the abutments have already been used clinically and treatment has been completed without issue, no additional patient intervention is required at this stage.
Replacement stock will be sent to customers as available. |
| Action Commencement Date |
8/07/2026 |
| Responsible Entity |
|
| Contact Information |
08 9466 2627 - Southern Implants Australia Support |