The Recall Desk
HighFDA (Devices)·Z-2421-2025·Announced 2025-09-03

Dental Prosthetics Device Atlantis IO FLO-S Recalled for Thread Engagement Defect

The Atlantis IO FLO-S dental prosthetics device has a defect preventing proper thread engagement with dental implants. Threads engage only about 2 rotations instead of the required 5, resulting in approximately 1mm less depth of engagement.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a medical device with a structural defect affecting proper engagement with dental implants. No injuries or hospitalizations have been reported in the source. As a risk-of-harm product where injury has not yet been reported, it meets the criterion for High severity.

Plain-English summary

The Atlantis IO FLO-S Kit is a dental prosthetics device manufactured by Dentsply IH, Inc. The device is intended to support prosthetic procedures by enabling digital impression taking on implant or abutment level, helping to restore chewing function in patients with partial or complete tooth loss.

The device has a defect in the thread area that prevents full engagement with a dental implant or analog (implant replica used for prosthetic modeling). The threads engage only approximately 2 rotations compared to the approximately 5 rotations required for full engagement, resulting in approximately 1mm difference in the depth of engagement.

A total of 102 units have been distributed worldwide, with US distribution in Illinois, Louisiana, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Texas, and West Virginia. The affected product model is A04B with catalog number 68020033, and the affected lot numbers are 10544044 and 10488578.

If you possess this device, verify the lot number against the identified affected lots. Those with affected devices should contact Dentsply IH, Inc. for further instructions or replacement.

The recalled product

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 wit
Manufacturer
Dentsply IH, Inc.
Category
Medical Device — Dental Prosthetics
Hazard
  • device-malfunction
  • structural-defect

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 (4)

  • Catalog / Ref #: 68020033
  • UDI-DI: 07392532249433
  • Lot #s: 10544044
  • 10488578

Distribution

Distributed nationwide across the United States.

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