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ATLANTIS™ 35511Recalls & reported problems

Dentsply Ih, Inc. · ATLANTIS Abutment Zr 10 · Class 2 · Implant

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07392532177248), received between Jun 2, 2026 and Jul 28, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (6 reports).

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 4 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture6

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 28, 2026Fracture

    It was reported that a patient experienced a dental abutment breakage.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50052929 ↗
  • InjuryJul 28, 2026Fracture

    It was reported that a patient experienced a dental abutment breakage.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50052631 ↗
  • InjuryJul 28, 2026Fracture

    It was reported that a patient experienced a dental abutment breakage.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50052629 ↗
  • InjuryJul 28, 2026Fracture

    It was reported that a patient experienced a dental abutment breakage.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50052474 ↗
  • InjuryJun 2, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25364286 ↗
  • InjuryJun 2, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25360839 ↗

Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices

All ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.