Recall archive / FDA device enforcement
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Descript... — FDA record Z-2422-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Dentsply IH, Inc.
- Quantity
- 780 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2422-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog / Ref #: 68020034; UDI: 07392532249440; Lot #s: 10515863, 10512084, 10505543, 10556741; |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 24, 2025
- Center classification date
- Aug 25, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.