Genesis ACTIVE GA21001Recalls & reported problems
Keystone Dental, Inc. · Genesis Active Conical Implant, Ø3.5x10.0mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI D768GA210010), received between Jan 17, 2024 and Jun 5, 2025 — classified as 15 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate15
Patient problems
- Inadequate Osseointegration15
- Osteopenia/ Osteoporosis4
- High Blood Pressure/ Hypertension2
- Implant Pain2
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20235937 ↗InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19818951 ↗InjuryJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19818902 ↗InjuryJun 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19467232 ↗InjuryMay 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19353943 ↗InjuryJan 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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