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.
What this means for you
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 che
- Manufacturer
- Dentsply IH, Inc.
- Hazard
- manufacturing-defect
- thread-engagement
- dental-implant
- class-ii
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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22