Dental implant locating kits recalled over thread defect limiting full engagement
Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice describes incomplete thread engagement without stating any patient harm.
Plain-English summary
The Atlantis IO FLO-S Kit, model and catalog number A04B / 68020033, UDI-DI 07392532249433, is being recalled for lots 10544044 and 10488578. The Atlantis intraoral feature locating object for suprastructures is used to support prosthetic work. The recall covers 102 units distributed in Illinois, Louisiana, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia, and internationally.
A defect in the thread area will not allow the device to fully engage with an implant or analog, the implant replica used for prosthetic modeling. The threads engage only about two rotations rather than the full engagement of about five, which equates to roughly a 1 mm difference in depth of engagement. The FDA classified the action as Class II.
Dental practices and laboratories holding these lots should quarantine them and follow the manufacturer's instructions for return 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.
- Hazard
- manufacturing-defect
- thread-engagement
- dental-implant
- class-ii
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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