| TGA Action ID |
RC-2026-RN-00873-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Southern Implants TSH1 prosthetic screws
Product Type: Prosthetic screw - Hexed Titanium Screw, M1.4, 2.25 mm Head Diameter
Item Code: TSH1
Lot Number: 113W13D7
Expiry Date: 02/07/2036 |
| ARTG Number |
450726 |
| Unique Device Identifier (UDI) |
06009544022725 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Units were packaged and labelled as TSH1 prosthetic screws but contain TSUZ3 prosthetic screws. The TSUZ3 screw differs from the intended TSH1 screw in overall length, major thread diameter, head geometry and connection interface.
The TSUZ3 screw is not suitable for the intended TSH1 prosthetic connection.
The dimensional and geometric differences between the TSUZ3 and TSH1 screws are visible through the transparent packaging. If the mismatch is not detected visually, the wider TSUZ3 screw is not expected to pass through or correctly engage with the prosthetic channel intended for the TSH1 screw.
The most reasonably foreseeable consequences are procedural delay, product replacement, additional chair time or an additional appointment.
No clinical harm has been reported. |
| Instructions for Customers/Users |
Customers are to:
- Immediately identify and quarantine all TSH1 units from Lot 113W13D7. Do not use, supply, transfer or dispose of the affected units.
- Return affected stock on hand with the completed response form.
Southern Implants Australia will arrange replacement or credit for returned affected stock. |
| Action Commencement Date |
27/10/2026 |
| Responsible Entity |
|
| Contact Information |
08 9466 2627 - Kaidee Flanagan, Southern Implants Australia |