Dental Atlantis IO FLO-S prosthetic device recalled for thread engagement defect
The Atlantis IO FLO-S dental prosthetic device has a thread engagement defect that prevents proper fitting with implants. Affected units may not seat correctly, potentially compromising prosthetic accuracy and function.
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: FDA Class II recall with a functional defect in a medical device used for patient care. While no injuries or illnesses are reported, the device malfunction poses a risk of improper prosthetic fitting and compromised digital impression accuracy, meeting the criteria for a risk-of-harm product without reported incidents.
Plain-English summary
The Atlantis IO FLO-S Kit (Model A04S), manufactured by Dentsply IH, Inc., is being recalled due to a defect in the device's thread engagement mechanism. The device is designed to support dental prosthetic procedures by enabling digital impression taking on implant or abutment surfaces.
The defect prevents the device from engaging fully with dental implants or analogs (replicas used for prosthetic modeling). The threads engage only approximately 2 rotations instead of the intended full engagement of approximately 5 rotations, resulting in approximately 1mm difference in depth of engagement. This malfunction could compromise the accuracy of digital impressions and proper device seating.
The recall affects 780 units distributed worldwide, including portions of the United States (Illinois, Louisiana, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Texas, and West Virginia), as well as Austria, Australia, Belgium, Canada, Germany, Denmark, Spain, Finland, France, Italy, Japan, Netherlands, Norway, Poland, Qatar, Sweden, Ukraine, and the United Kingdom. Affected lots are: 10515863, 10512084, 10505543, and 10556741.
Patients and dental professionals should discontinue use of affected units. Contact Dentsply IH, Inc. for guidance on device replacement or proper handling of affected inventory.
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
- thread-defect
- improper-fit
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.
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