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ASTRA TECH Implant System EVRecalls & reported problems across all models

Dentsply Implants Manufacturing GmbH · 177 models in the FDA device registry

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

Adverse event reports
37,200
Deaths reported
0
Injuries reported
37,156
Recalls
0

We found 177 models of ASTRA TECH Implant System EV by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 37,200 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2016 and Sep 30, 2026 — classified as 37,156 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (25,367 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: 782 reportsDec 2023: 633 reportsJan 2024: 1,327 reportsFeb 2024: 983 reportsMar 2024: 900 reportsApr 2024: 1,058 reportsMay 2024: 881 reportsJun 2024: 965 reportsJul 2024: 726 reportsAug 2024: 774 reportsSep 2024: 1,101 reportsOct 2024: 1,132 reportsNov 2024: 785 reportsDec 2024: 380 reportsJan 2025: 1,075 reportsFeb 2025: 630 reportsMar 2025: 1,586 reportsApr 2025: 313 reportsMay 2025: 680 reportsJun 2025: 1,099 reportsJul 2025: 1,614 reportsAug 2025: 1,326 reportsSep 2025: 712 reportsOct 2025: 604 reportsNov 2025: 933 reportsDec 2025: 1,088 reportsJan 2026: 1,356 reportsFeb 2026: 921 reportsMar 2026: 1,015 reportsApr 2026: 1,682 reportsMay 2026: 787 reportsJun 2026: 1,042 reportsJul 2026: 1,052 reportsAug 2026: 609 reportsSep 2026: 888 reportsOct 2026: 0 reports2024202520261,682
Last 36 months. The most recent month may be incomplete.

Most reported ASTRA TECH Implant System EV problems

Device problems

  • Failure to Osseointegrate25,367
  • Loss of Osseointegration10,184
  • Fracture1,385
  • Off-Label Use409
  • Insufficient Device Problem Information151
  • Crack93
  • Malposition of Device86
  • Separation Failure47

Patient problems

  • Failure of Implant36,138
  • Unspecified Infection8,079
  • Inflammation4,997
  • Osteolysis3,044
  • Pocket Erosion2,399
  • No Clinical Signs, Symptoms or Conditions589
  • Inadequate Osseointegration460
  • Implant Pain291

ASTRA TECH Implant System EV models

177 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 EV 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