Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / ...
FDA Device Recall #Z-2421-2025 — Class II — July 24, 2025
Recall Summary
| Recall Number | Z-2421-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 24, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Dentsply IH, Inc. |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 102 units |
Product Description
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
Reason for Recall
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK.
Lot / Code Information
Catalog / Ref #: 68020033; UDI-DI: 07392532249433; Lot #s: 10544044, 10488578;
Other Recalls from Dentsply IH, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2422-2025 | Class II | Brand Name: Atlantis IO FLO Product Name: Atla... | Jul 24, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.