FDAJuly 24, 2025device
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 par...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
dentsply ihdentsply
UPCs
07392532249440
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand 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 restorin...2025-07-24
- FDALoFric Origo, Tiemann, 16in, FR14 urinary catheters2020-06-17
- FDALoFric Origo, Tiemann, 16in, FR12 urinary catheters2020-06-17
- FDALoFric Origo, Nelaton, 16in, FR10 urinary catheters2020-06-17
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