Genesis Implant System G21130Recalls & reported problems

Keystone Dental, Inc. · Implant · Class 2 · Implant

All models of Genesis Implant System (22)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Keystone Dental Genesis implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Most of the 114 reports describe the implant failing to bond with the jawbone, and 51 list an implant failure. The reports include 114 injuries and no deaths. Reports fell to 1 in the last 12 months from 17 in the previous 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: 116
Deaths reported: 0
Injuries reported: 116
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI D768G211300), received between Dec 13, 2019 and Sep 30, 2026 — classified as 116 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (88 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate88
Loss of Osseointegration25
Fracture3

Patient problems

Inadequate Osseointegration65
Failure of Implant51
Osteopenia/ Osteoporosis16
Implant Pain7
Unspecified Infection7
Bacterial Infection4
Pain4
High Blood Pressure/ Hypertension2

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Loss of Osseointegration
Loss of Osseointegration.
Patient problems: Inadequate Osseointegration
MAUDE report 50942849 ↗
InjurySep 15, 2026Fracture
Implant Fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770593 ↗
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 23609667 ↗
InjurySep 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 23038243 ↗
InjurySep 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22978248 ↗
InjurySep 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22957117 ↗
InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22939108 ↗
InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22574788 ↗
InjuryJul 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22519733 ↗
InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22350213 ↗
InjuryJun 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22339006 ↗
InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22142591 ↗
InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22107561 ↗
InjuryMay 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21944744 ↗
InjuryApr 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21774874 ↗
InjuryMar 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21652458 ↗
InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21378700 ↗
InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21170558 ↗
InjuryJan 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21151792 ↗
InjuryDec 27, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21028995 ↗
InjuryOct 28, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20543902 ↗
InjuryOct 9, 2024Fracture; Fracture
IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 20410648 ↗
InjuryOct 9, 2024Fracture; Fracture
IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 20410395 ↗
InjurySep 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20217580 ↗
InjurySep 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Unspecified Infection
MAUDE report 20200979 ↗

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 · Terminated
Genesis 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 · Terminated
Genesis 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 · Terminated
Genesis 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

Device details

UDI-DI	`D768G211300`
Brand	Genesis Implant System
Model	G21130
Company	Keystone Dental, Inc.
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	K101545
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 31, 2021

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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