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
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.
- Astra Tech Implant System® EV 26313IMPLANT, ENDOSSEOUS, ROOT-FORM3,020 reports
- Astra Tech Implant System® EV 26312IMPLANT, ENDOSSEOUS, ROOT-FORM2,280 reports
- Astra Tech Implant System® EV 26322IMPLANT, ENDOSSEOUS, ROOT-FORM2,174 reports
- Astra Tech Implant System® EV 26323IMPLANT, ENDOSSEOUS, ROOT-FORM2,017 reports
- ASTRA TECH Implant System® EV 25233IMPLANT, ENDOSSEOUS, ROOT-FORM1,404 reports
- ASTRA TECH Implant System® EV 25224IMPLANT, ENDOSSEOUS, ROOT-FORM1,344 reports
- Astra Tech Implant System® EV 26342IMPLANT, ENDOSSEOUS, ROOT-FORM1,212 reports
- Astra Tech Implant System® EV 26321IMPLANT, ENDOSSEOUS, ROOT-FORM1,158 reports
- ASTRA TECH Implant System® EV 25234IMPLANT, ENDOSSEOUS, ROOT-FORM1,107 reports
- Astra Tech Implant System® EV 26311IMPLANT, ENDOSSEOUS, ROOT-FORM1,018 reports
- ASTRA TECH Implant System® EV 25243IMPLANT, ENDOSSEOUS, ROOT-FORM987 reports
- ASTRA TECH Implant System® EV 25223IMPLANT, ENDOSSEOUS, ROOT-FORM982 reports
- ASTRA TECH Implant System® EV 25232IMPLANT, ENDOSSEOUS, ROOT-FORM873 reports
- ASTRA TECH Implant System® EV 25214IMPLANT, ENDOSSEOUS, ROOT-FORM778 reports
- Astra Tech Implant System® EV 26341IMPLANT, ENDOSSEOUS, ROOT-FORM775 reports
- Astra Tech Implant System® EV 26343IMPLANT, ENDOSSEOUS, ROOT-FORM764 reports
- ASTRA TECH Implant System® EV 25242IMPLANT, ENDOSSEOUS, ROOT-FORM747 reports
- Astra Tech Implant System® EV 26314IMPLANT, ENDOSSEOUS, ROOT-FORM679 reports
- Astra Tech Implant System® EV 26332IMPLANT, ENDOSSEOUS, ROOT-FORM676 reports
- Astra Tech Implant System® EV 26303IMPLANT, ENDOSSEOUS, ROOT-FORM642 reports
- Astra Tech Implant System® EV 26333IMPLANT, ENDOSSEOUS, ROOT-FORM624 reports
- ASTRA TECH Implant System® EV 25244IMPLANT, ENDOSSEOUS, ROOT-FORM605 reports
- Astra Tech Implant System® EV 26320IMPLANT, ENDOSSEOUS, ROOT-FORM582 reports
- ASTRA TECH Implant System® EV 25231IMPLANT, ENDOSSEOUS, ROOT-FORM513 reports
- Astra Tech Implant System® EV 26324IMPLANT, ENDOSSEOUS, ROOT-FORM458 reports
- ASTRA TECH Implant System® EV 25241IMPLANT, ENDOSSEOUS, ROOT-FORM455 reports
- ASTRA TECH Implant System® EV 25222IMPLANT, ENDOSSEOUS, ROOT-FORM413 reports
- Astra Tech Implant System® EV 26352IMPLANT, ENDOSSEOUS, ROOT-FORM410 reports
- ASTRA TECH Implant System® EV 25225IMPLANT, ENDOSSEOUS, ROOT-FORM385 reports
- Astra Tech Implant System® EV 26310IMPLANT, ENDOSSEOUS, ROOT-FORM381 reports
- ASTRA TECH Implant System® EV 25263IMPLANT, ENDOSSEOUS, ROOT-FORM361 reports
- Astra Tech Implant System® EV 26340IMPLANT, ENDOSSEOUS, ROOT-FORM355 reports
- ASTRA TECH Implant System® EV 25264IMPLANT, ENDOSSEOUS, ROOT-FORM316 reports
- ASTRA TECH Implant System® EV 25273IMPLANT, ENDOSSEOUS, ROOT-FORM295 reports
- Astra Tech Implant System® EV 26362IMPLANT, ENDOSSEOUS, ROOT-FORM284 reports
- Astra Tech Implant System® EV 26353IMPLANT, ENDOSSEOUS, ROOT-FORM282 reports
- ASTRA TECH Implant System® EV 25235IMPLANT, ENDOSSEOUS, ROOT-FORM270 reports
- Astra Tech Implant System® EV 26302IMPLANT, ENDOSSEOUS, ROOT-FORM262 reports
- ASTRA TECH Implant System® EV 25215IMPLANT, ENDOSSEOUS, ROOT-FORM248 reports
- ASTRA TECH Implant System® EV 25274IMPLANT, ENDOSSEOUS, ROOT-FORM238 reports
- Astra Tech Implant System® EV 26363IMPLANT, ENDOSSEOUS, ROOT-FORM220 reports
- Astra Tech Implant System® EV 26331IMPLANT, ENDOSSEOUS, ROOT-FORM218 reports
- ASTRA TECH Implant System® EV 25253IMPLANT, ENDOSSEOUS, ROOT-FORM215 reports
- Astra Tech Implant System® EV 26361IMPLANT, ENDOSSEOUS, ROOT-FORM200 reports
- Astra Tech Implant System® EV 26351IMPLANT, ENDOSSEOUS, ROOT-FORM190 reports
- Astra Tech Implant System® EV 26304IMPLANT, ENDOSSEOUS, ROOT-FORM185 reports
- ASTRA TECH Implant System® EV 25265IMPLANT, ENDOSSEOUS, ROOT-FORM172 reports
- ASTRA TECH Implant System® EV 25252IMPLANT, ENDOSSEOUS, ROOT-FORM169 reports
- ASTRA TECH Implant System® EV 25254IMPLANT, ENDOSSEOUS, ROOT-FORM166 reports
- ASTRA TECH Implant System® EV 25251IMPLANT, ENDOSSEOUS, ROOT-FORM155 reports
- ASTRA TECH Implant System® EV 25272IMPLANT, ENDOSSEOUS, ROOT-FORM150 reports
- Astra Tech Implant System® EV 26334IMPLANT, ENDOSSEOUS, ROOT-FORM144 reports
- ASTRA TECH Implant System® EV 25262IMPLANT, ENDOSSEOUS, ROOT-FORM134 reports
- Astra Tech Implant System® EV 26372IMPLANT, ENDOSSEOUS, ROOT-FORM120 reports
- Astra Tech Implant System® EV 26373IMPLANT, ENDOSSEOUS, ROOT-FORM117 reports
- Astra Tech Implant System® EV 26360IMPLANT, ENDOSSEOUS, ROOT-FORM114 reports
- Astra Tech Implant System® EV 26301IMPLANT, ENDOSSEOUS, ROOT-FORM110 reports
- Astra Tech Implant System® EV 26402IMPLANT, ENDOSSEOUS, ROOT-FORM105 reports
- ASTRA TECH Implant System® EV 25221IMPLANT, ENDOSSEOUS, ROOT-FORM102 reports
- Astra Tech Implant System® EV 26344IMPLANT, ENDOSSEOUS, ROOT-FORM101 reports
- ASTRA TECH Implant System® EV 25245IMPLANT, ENDOSSEOUS, ROOT-FORM100 reports
- ASTRA TECH Implant System® EV 25275IMPLANT, ENDOSSEOUS, ROOT-FORM86 reports
- Astra Tech Implant System® EV 26315IMPLANT, ENDOSSEOUS, ROOT-FORM78 reports
- ASTRA TECH Implant System® EV 25213IMPLANT, ENDOSSEOUS, ROOT-FORM75 reports
- Astra Tech Implant System® EV 26383IMPLANT, ENDOSSEOUS, ROOT-FORM70 reports
- Astra Tech Implant System® EV 26401IMPLANT, ENDOSSEOUS, ROOT-FORM70 reports
- Astra Tech Implant System® EV 26371IMPLANT, ENDOSSEOUS, ROOT-FORM67 reports
- Astra Tech Implant System® EV 26403IMPLANT, ENDOSSEOUS, ROOT-FORM56 reports
- Astra Tech Implant System® EV 26382IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- Astra Tech Implant System® EV 26354IMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- Astra Tech Implant System® EV 26364IMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- Astra Tech Implant System® EV 26325IMPLANT, ENDOSSEOUS, ROOT-FORM45 reports
- ASTRA TECH Implant System® EV 25442IMPLANT, ENDOSSEOUS, ROOT-FORM43 reports
- ASTRA TECH Implant System® EV 25441IMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- ASTRA TECH Implant System® EV 25212IMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- Astra Tech Implant System® EV 26381IMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- ASTRA TECH Implant System® EV 25226IMPLANT, ENDOSSEOUS, ROOT-FORM37 reports
- Astra Tech Implant System® EV 26413IMPLANT, ENDOSSEOUS, ROOT-FORM36 reports
- ASTRA TECH Implant System® EV 25255IMPLANT, ENDOSSEOUS, ROOT-FORM32 reports
- ASTRA TECH Implant System® EV 25448IMPLANT, ENDOSSEOUS, ROOT-FORM32 reports
- ASTRA TECH Implant System® EV 25454IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Astra Tech Implant System® EV 26412IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- ASTRA TECH Implant System® EV 25447IMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- ASTRA TECH Implant System® EV 25216IMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- ASTRA TECH Implant System® EV 25453IMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- ASTRA TECH Implant System® EV 25459IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Astra Tech Implant System® EV 26374IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Astra Tech Implant System® EV 26384IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- ASTRA TECH Implant System® EV 25236IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- Astra Tech Implant System® EV 26411IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- ASTRA TECH Implant System® EV 25481IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Astra Tech Implant System® EV 26305IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- ASTRA TECH Implant System® EV 25440IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- ASTRA TECH Implant System® EV 25452IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- ASTRA TECH Implant System® EV 25460IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Astra Tech Implant System® EV 26335IMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- ASTRA TECH Implant System® EV 25246IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- ASTRA TECH Implant System® EV 25446IMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- ASTRA TECH Implant System® EV 25458IMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- ASTRA TECH Implant System® EV 25443IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
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.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954042 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953673 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953557 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953523 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953385 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50953363 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953207 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953087 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952958 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952837 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis
MAUDE report 50952749 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952670 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952656 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952655 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952639 ↗
Other Dentsply Implants Manufacturing GmbH products
All Dentsply Implants Manufacturing GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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