Genesis Implant System G21132Recalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Genesis implant is a root-form dental implant placed into the jawbone. All 163 of its adverse event reports are injuries, with no deaths. Most describe the implant not bonding with the bone or losing that bond, and reports also mention low bone density (osteopenia or osteoporosis) and pain. Reports fell from 21 in the prior 12 months to 4 in the last 12 months. 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
- 163
- Deaths reported
- 0
- Injuries reported
- 163
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI D768G211320), received between Dec 30, 2019 and Mar 30, 2026 — classified as 163 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (140 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate140
- Loss of Osseointegration22
- Failure to Disconnect1
- Fracture1
Patient problems
- Inadequate Osseointegration84
- Failure of Implant53
- Osteopenia/ Osteoporosis36
- Implant Pain25
- High Blood Pressure/ Hypertension14
- Unspecified Infection12
- Osteolysis10
- Pain8
Recent adverse event reports
The 25 most recent of 163 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Loss of Osseointegration
InjuryFeb 15, 2026Loss of Osseointegration
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23289287 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 23003032 ↗InjuryAug 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 22804321 ↗InjuryJul 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22336888 ↗InjuryJun 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21913552 ↗InjuryApr 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21912644 ↗InjuryApr 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21378091 ↗InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20905729 ↗InjuryNov 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 20746542 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20662882 ↗
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 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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