Recall Z-2421-2025 ยท NDP Accessories, Implant, Dental, Endosseous
Dentsply IH, Inc.
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
| Date | Aug 25, 2025 (initiated Jul 24, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On July 24, 2025, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action to be taken by the Customer: 1. Stop use of the affected lots immediately. 2. If the IO FLO-S has already been used for scanning, please immediately contact the dental laboratory that manufactured the dental restoration and direct the laboratory to contact Dentsply Sirona Atlantis Customer Service, immediately (see contact data below) to verify if the scans are correct. 3. If the IO FLO-S has already been used and a structure has been manufactured and placed into the patient, please immediately contact the p |
| Quantity | 102 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.