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

FDA device recall Z-2421-2025 · posted 2025-08-25 · Open, Classified

Recall details

Recalling firm

Dentsply IH, Inc.

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NDP

Quantity affected

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.

Date initiated

2025-07-24

Date posted

2025-08-25

Location

Waltham, MA