Genesis Implant System G21146Recalls & 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 System G21146 is a root-form dental implant used as a tooth replacement anchor in the jaw. The 75 reports describe the implant failing to fuse with the surrounding bone, or losing that fusion after surgery, along with pain and cases of low bone density. All 75 involved injuries and no deaths. There are no recalls naming 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
- 75
- Deaths reported
- 0
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI D768G211460), received between Nov 19, 2019 and Aug 18, 2026 — classified as 75 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (57 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 Osseointegrate57
- Loss of Osseointegration18
Patient problems
- Inadequate Osseointegration42
- Failure of Implant23
- Osteopenia/ Osteoporosis17
- Implant Pain14
- High Blood Pressure/ Hypertension6
- Pain4
- Bacterial Infection3
- Unspecified Infection3
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Loss of Osseointegration
Loss of Osseointegration.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50293188 ↗InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23426753 ↗InjurySep 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22978333 ↗InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 22938469 ↗InjuryAug 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22798089 ↗InjuryJun 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 22203789 ↗InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 25, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20535060 ↗InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20384593 ↗InjurySep 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20271052 ↗InjuryAug 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19985162 ↗InjuryJul 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19249772 ↗InjuryDec 18, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18343807 ↗InjurySep 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 17829127 ↗InjurySep 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 8, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17711248 ↗
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-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
- 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
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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