Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2422-2025·Announced 2025-09-03

Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement

Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice describes incomplete thread engagement without stating any patient harm.

Plain-English summary

The Atlantis IO FLO-S Kit, model and catalog number A04S / 68020034, UDI 07392532249440, is being recalled for lots 10515863, 10512084, 10505543 and 10556741. The Atlantis intraoral feature locating object for suprastructures is used to support the prosthetic procedure. The recall covers 780 units distributed in Illinois, Louisiana, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia, and internationally.

A defect in the thread area will not allow the device to fully engage with an implant or analog, the implant replica used for prosthetic modeling. The threads engage only about two rotations rather than the full engagement of about five, which equates to roughly a 1 mm difference in depth of engagement. The FDA classified the action as Class II.

Dental practices and laboratories holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.

The recalled product

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…
Manufacturer: Dentsply IH, Inc.
Category: Medical Device — Dental Equipment
Hazard: manufacturing-defect
thread-engagement
dental-implant
class-ii
Affected units: 780

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Catalog / Ref #: 68020034
UDI: 07392532249440
Lot #s: 10515863
10512084
10505543
10556741

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Dentsply IH, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Dentsply IH, Inc.

See all →

Moderate
Dental implant locating kits recalled over thread defect limiting full engagement
FDA (Devices) · 2025-09-03

Same hazard · manufacturing defect