Genesis Implant SystemRecalls & reported problems across all models
Keystone Dental, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,310
- Deaths reported
- 0
- Injuries reported
- 2,310
- Recalls
- 0
We found 22 models of Genesis Implant System by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 2,310 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2019 and Sep 30, 2026 — classified as 2,310 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,840 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 Implant System problems
Device problems
- Failure to Osseointegrate1,840
- Loss of Osseointegration457
- Fracture9
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Deformation Due to Compressive Stress1
- Device Damaged by Another Device1
- Failure to Disconnect1
Patient problems
- Inadequate Osseointegration1,304
- Failure of Implant659
- Osteopenia/ Osteoporosis426
- Implant Pain378
- Unspecified Infection196
- High Blood Pressure/ Hypertension177
- Pain160
- Osteolysis79
Genesis Implant System models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Genesis Implant System G21138IMPLANT, ENDOSSEOUS, ROOT-FORM308 reports
- Genesis Implant System G21145IMPLANT, ENDOSSEOUS, ROOT-FORM198 reports
- Genesis Implant System G21139IMPLANT, ENDOSSEOUS, ROOT-FORM197 reports
- Genesis Implant System G21144IMPLANT, ENDOSSEOUS, ROOT-FORM190 reports
- Genesis Implant System G21137IMPLANT, ENDOSSEOUS, ROOT-FORM186 reports
- Genesis Implant System G21132IMPLANT, ENDOSSEOUS, ROOT-FORM163 reports
- Genesis Implant System G21131IMPLANT, ENDOSSEOUS, ROOT-FORM149 reports
- Genesis Implant System G21140IMPLANT, ENDOSSEOUS, ROOT-FORM138 reports
- Genesis Implant System G21050IMPLANT, ENDOSSEOUS, ROOT-FORM119 reports
- Genesis Implant System G21133IMPLANT, ENDOSSEOUS, ROOT-FORM118 reports
- Genesis Implant System G21130IMPLANT, ENDOSSEOUS, ROOT-FORM116 reports
- Genesis Implant System G21051IMPLANT, ENDOSSEOUS, ROOT-FORM88 reports
- Genesis Implant System G21146IMPLANT, ENDOSSEOUS, ROOT-FORM75 reports
- Genesis Implant System G21052IMPLANT, ENDOSSEOUS, ROOT-FORM61 reports
- Genesis Implant System G21151IMPLANT, ENDOSSEOUS, ROOT-FORM53 reports
- Genesis Implant System G21150IMPLANT, ENDOSSEOUS, ROOT-FORM37 reports
- Genesis Implant System G21147IMPLANT, ENDOSSEOUS, ROOT-FORM35 reports
- Genesis Implant System G21152IMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Genesis Implant System G21142IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Genesis Implant System G21135IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Genesis Implant System G21053IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Genesis Implant System G21153IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
Recent Genesis Implant System 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
InjurySep 15, 2026Fracture
InjurySep 15, 2026Loss of Osseointegration
Loss of Osseointegration.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50768889 ↗InjurySep 15, 2026Loss of Osseointegration
Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 50767620 ↗InjuryAug 18, 2026Loss of Osseointegration
Loss of Osseointegration.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50293188 ↗InjuryAug 5, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryMay 3, 2026Loss of Osseointegration
InjuryApr 26, 2026Loss of Osseointegration
InjuryMar 30, 2026Loss of Osseointegration
InjuryFeb 15, 2026Loss of Osseointegration
InjuryJan 27, 2026Loss of Osseointegration
InjuryJan 27, 2026Loss of Osseointegration
InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 21, 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.
How reports and recalls are matched · Editorial policy · Report an error on this page