Genesis ACTIVERecalls & reported problems across all models
Keystone Dental, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 234
- Deaths reported
- 0
- Injuries reported
- 234
- Recalls
- 0
We found 15 models of Genesis ACTIVE by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 234 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2023 and Sep 9, 2025 — classified as 234 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (229 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 Genesis ACTIVE problems
Device problems
- Failure to Osseointegrate229
- Loss of Osseointegration5
Patient problems
- Inadequate Osseointegration234
- Implant Pain57
- Osteopenia/ Osteoporosis53
- Unspecified Infection30
- High Blood Pressure/ Hypertension21
- Bruxism13
- Foreign Body Reaction3
- Sinus Perforation3
Genesis ACTIVE models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Genesis ACTIVE GA21011IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Genesis ACTIVE GA21012IMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- Genesis ACTIVE GA21015IMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Genesis ACTIVE GA21016IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Genesis ACTIVE GA21006IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Genesis ACTIVE GA21002IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- Genesis ACTIVE GA21013IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- Genesis ACTIVE GA21001IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Genesis ACTIVE GA21008IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Genesis ACTIVE GA21007IMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Genesis ACTIVE GA21005IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Genesis ACTIVE GA21003IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Genesis ACTIVE GA21010IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- Genesis ACTIVE GA21017IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Genesis ACTIVE GA21014IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
Recent Genesis ACTIVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003536 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003534 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003533 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003531 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003529 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003526 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003525 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23002943 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23002938 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23002935 ↗InjurySep 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
Other Keystone Dental, Inc. products
All Keystone Dental, Inc. 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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