| TGA Action ID |
RC-2025-RN-00649-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
IO FLO-S Kit A04A and A04S
Article Numbers: 68020032, 68020034
UDI: 07392532249426, 07392532249440
Lot Numbers: 10529852, 10512084 |
| ARTG Number |
343155 |
| Unique Device Identifier (UDI) |
07392532249426 (68020032), 07392532249440 (68020034) |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Due to a defect in the thread area of certain affected IO FLO-S, the device may not fully engage or seat with an abutment as intended. This defect results in an unintended gap between the IO FLO-S and the abutment.
Due to the problem, scans performed using an affected IO FLO-S device may produce inaccurate dental restorations, which can lead to poor fit and compromise the mechanical stability between the abutment and the restoration, potentially resulting in gaps. |
| Instructions for Customers/Users |
Customers are to:
· Inspect their stock immediately, quarantine any affected stock on hand, and stop using the affected lots without delay.
· Contact the dental laboratory immediately if the IO FLO-S has already been used for scanning. The laboratory should then reach out to Dentsply Sirona Atlantis Customer Service to verify the accuracy of the scans.
· Contact the patient immediately if a structure manufactured using the IO FLO-S has already been placed. Please verify the correct engagement of the supra structure, proper fit, and torque of the prosthetic screws. Also, contact your local Dentsply Sirona Atlantis Customer Service without delay.
· Complete the Customer Response form to assist with reconciliation. Return any affected stock along with the completed form for a refund or replacement. Note: If you are unable to identify the affected lots, please return all products of the affected types.
This action has been closed out on 12/05/2026 |
| Action Commencement Date |
25/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 55 29 29 - Dentsply Sirona Customer Care |