Genesis ACTIVE GA21003Recalls & reported problems
Keystone Dental, Inc. · Genesis Active Conical Implant, Ø3.5x13.0mm · Class 2 · Implant
All models of Genesis ACTIVE (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D768GA210030), received between Jun 25, 2024 and Sep 9, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate9
Patient problems
- Inadequate Osseointegration9
- Implant Pain3
- Osteopenia/ Osteoporosis2
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, 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 23002935 ↗InjurySep 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22737512 ↗InjuryJun 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21980304 ↗InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
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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 14, 2026 · each report above links to its original FDA record
- 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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