Dentsply IH, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2421-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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 with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component

Product Classification:

Class II

Date Initiated: July 24, 2025

Date Posted: September 3, 2025

Recall Number: Z-2421-2025

Event ID: 97305

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.

Status: Ongoing

Product Quantity: 102 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated