# FDA recall Z-2422-2025

> **Dentsply IH, Inc.** · Class II · device recall initiated 2025-07-24.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2422-2025
- **Recalling firm:** Dentsply IH, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-24
- **Report date:** 2025-09-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2422-2025

## Citation

> AI Analytics. FDA recall Z-2422-2025. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2422-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*