Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit… — Class II medical device recall Z-2422-2025
Ongoing recall by Dentsply IH, Inc., reported 2025-09-03, distributed nationwide. The defect in the thread area will not allow the device to fully engage with an implant or analog (implant rep
| Recall number | Z-2422-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dentsply IH, Inc., Waltham, MA, United States |
| Recall initiated | 2025-07-24 |
| Classified | 2025-08-25 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 780 units |
| UPC / GTIN / UDI-DI | 07392532249440 |
| Lot numbers | 10505543, 10512084, 10515863, 10556741 |
| Model numbers | 68020034, 6802034, A04S |
Product
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2422-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.