Z-2421-2025Class II

Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033...

Name: Z-2421-2025 Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033...
Creator: Dentsply IH, Inc.
Published: 2025-07-24
License: https://open.fda.gov/license/

Dentsply IH BV / initiated 2025-07-24 / Open, Classified

FDA source

Dentsply IH, Inc. began a recall of 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... on 2025-07-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2421-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-24
Posted: 2025-08-25
Recalling firm: Dentsply IH BV
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 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
Product code: NDP Accessories, Implant, Dental, Endosseous
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.
FDA root cause: Under Investigation by firm
Action: On July 24, 2025, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action to be taken by the Customer: 1. Stop use of the affected lots immediately. 2. If the IO FLO-S has already been used for scanning, please immediately contact the dental laboratory that manufactured the dental restoration and direct the laboratory to contact Dentsply Sirona Atlantis Customer Service, immediately (see contact data below) to verify if the scans are correct. 3. If the IO FLO-S has already been used and a structure has been manufactured and placed into the patient, please immediately contact the patient and verify the correct engagement of the suprastructure, correct fit and torque of the prosthetic screws. Please contact your local Dentsply Sirona Atlantis Customer Service, immediately (see contact data below). 4. Return any affected lots for refund or replacement to the address below by including the completed and signed Answer Letter (see page 3). If unable to identify the affected lots, please return all products of the affected types. Dentsply IH Inc Attn: QA Department 590 Lincoln St Waltham, MA 02451 5. Please return the completed and signed Answer Letter (page 3 of this document) to the local Dentsply Sirona country organization identified above within one week after receipt of this Urgent Medical Device Recall Notice. Timely completion will allow us to process your replacement product more quickly. Transmission of this Urgent Medical Device Recall Notice Please provide this Notice to everyone that needs to be aware of this issue inside or outside of your organization. Specifically, please provide this Notice to any organization where the potentially affected product(s) have been transferred or used within the workflow to create a patient-specific restoration, or where this issue may have an impact. Please continue to review and abide by this Notice for an adequate timeframe so all affected products are identified, and appropriate measure are taken Please repor
Quantity in commerce: 102 units
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.
Product codes and lots: Catalog / Ref #: 68020033; UDI-DI: 07392532249433; Lot #s: 10544044, 10488578;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2421-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2421-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-25
Z-2422-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-25

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)