Genesis Implant System G21147Recalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Genesis Implant System (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Dental Genesis Implant is a root-form endosseous dental implant used to replace missing teeth. The 35 reports describe implants that failed to fuse properly with the surrounding bone, sometimes after already having fused, along with implant pain and infection. No deaths were reported; all 35 reports involve injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI D768G211470), received between Dec 30, 2019 and Jan 3, 2025 — classified as 35 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (32 reports).
3 other recalls cover devices cleared under the same FDA submission (K101545); they may or may not involve this specific model.
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 Osseointegrate32
- Loss of Osseointegration3
Patient problems
- Failure of Implant16
- Inadequate Osseointegration12
- Osteopenia/ Osteoporosis6
- High Blood Pressure/ Hypertension3
- Implant Pain3
- Unspecified Infection3
- Osteolysis1
- Pain1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21072444 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 19359411 ↗InjuryApr 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 19164160 ↗InjuryApr 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 16585747 ↗InjuryOct 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15615666 ↗InjurySep 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 15381493 ↗InjuryMar 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Pain
MAUDE report 13732948 ↗InjuryJan 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 2, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryJan 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 1, 2020Loss of Osseointegration; Loss of Osseointegration
InjurySep 4, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 16, 2020Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K101545. One submission often covers many models, so check the product and lot details in each record.
- Z-1485-2018 · Mar 13, 2018 · TerminatedGenesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
- Z-0924-2013 · Jul 5, 2011 · TerminatedGenesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or ful
- Z-0923-2013 · Jul 5, 2011 · TerminatedGenesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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