Device recall
Z-2421-2025: Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog…
FDA device recall · Class II · Dentsply IH, Inc.
Key facts
| Recall number (Z-number) | Z-2421-2025 |
|---|---|
| Recall event | 97305 |
| Product | 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… |
| Product code | NDP |
| Recalling firm | Dentsply IH, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000120733 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database