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ASTRA TECH Implant SystemRecalls & reported problems across all models

Dentsply Implants Manufacturing GmbH · 166 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
27,749
Deaths reported
0
Injuries reported
27,487
Recalls
0

We found 166 models of ASTRA TECH Implant System by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 27,749 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2023 and Sep 30, 2026 — classified as 27,487 injuries, 262 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (13,527 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 734 reportsDec 2023: 456 reportsJan 2024: 848 reportsFeb 2024: 856 reportsMar 2024: 723 reportsApr 2024: 912 reportsMay 2024: 627 reportsJun 2024: 975 reportsJul 2024: 685 reportsAug 2024: 855 reportsSep 2024: 845 reportsOct 2024: 792 reportsNov 2024: 731 reportsDec 2024: 273 reportsJan 2025: 823 reportsFeb 2025: 405 reportsMar 2025: 1,149 reportsApr 2025: 192 reportsMay 2025: 417 reportsJun 2025: 654 reportsJul 2025: 1,060 reportsAug 2025: 892 reportsSep 2025: 527 reportsOct 2025: 388 reportsNov 2025: 510 reportsDec 2025: 602 reportsJan 2026: 844 reportsFeb 2026: 483 reportsMar 2026: 701 reportsApr 2026: 769 reportsMay 2026: 600 reportsJun 2026: 583 reportsJul 2026: 884 reportsAug 2026: 450 reportsSep 2026: 449 reportsOct 2026: 0 reports2024202520261,149
Last 36 months. The most recent month may be incomplete.

Most reported ASTRA TECH Implant System problems

Device problems

  • Failure to Osseointegrate13,527
  • Loss of Osseointegration12,755
  • Fracture1,304
  • Off-Label Use207
  • Mechanical Problem105
  • Crack68
  • Damaged Thread37
  • Insufficient Device Problem Information35

Patient problems

  • Failure of Implant26,844
  • Unspecified Infection5,848
  • Inflammation5,296
  • Osteolysis2,279
  • Pocket Erosion2,025
  • No Clinical Signs, Symptoms or Conditions604
  • Inadequate Osseointegration265
  • Implant Pain76

ASTRA TECH Implant System models

166 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

Recent ASTRA TECH Implant System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Dentsply Implants Manufacturing GmbH products

All Dentsply Implants Manufacturing GmbH devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page