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Astra Tech Implant System® 26029Recalls & reported problems

Dentsply Implants Manufacturing GmbH · 4/V-Sleeve Ø3.7 WD · Class 1

All models of ASTRA TECH Implant System (166)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532168680), received between Jan 2, 2026 and Jan 13, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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: 2 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem2
  • Device Misassembled During Manufacturing /Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 13, 2026Mechanical Problem; Device Misassembled During Manufacturing /Shipping

    IT WAS REPORTED THAT THE DRILL SLEEVE DID NOT FIT PROPERLY ON THE DRILL DURING USE. NO INJURY TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24056418 ↗
  • MalfunctionJan 2, 2026Mechanical Problem

    IT WAS REPORTED THAT A CUSTOMER ENCOUNTERED AN DRILL SLEEVE FRACTURE WHEN PLACING ON TO THE DRILL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23952563 ↗

Other Accessories, implant, dental, endosseous devices

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Sources and updates

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