ATLANTIS® 35229Recalls & reported problems
Dentsply Implants Manufacturing GmbH · IO FLO IO-H-02 · Class 1 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07392532160646), received between Feb 3, 2026 and May 22, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Mechanical Problem1
- Separation Failure1
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2026Fracture
IT WAS REPORTED A PIECE OF THE DEVICE GOT STUCK IN THE IMPLANT AND THE PLASTIC PART SEPARATED WHEN REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257681 ↗InjuryApr 11, 2026Mechanical Problem
IT WAS REPORTED, THAT AN IMPLANT "BECAME LODGED AND DAMAGED" WITH THE ATLANTIS IO FLO.THE INVOLVED IMPLANT WAS NOT A DENTSPLY SIRONA PRODUCT.
Patient problems: Failure of Implant
MAUDE report 24848206 ↗InjuryFeb 3, 2026Separation Failure
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.