Legacy™3 Implant 864210Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.2mmD x 10mmL, 3.5mmD Platform · Class 2 · Implant
All models of Legacy3 Implant (75)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct Legacy 3 dental implant is placed in the jaw to support a replacement tooth. The 25 reports describe the implant failing to bond with the bone or loosening afterward, with some mentioning infection, inflammation or pain, including 25 injuries and no deaths. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10841307102519), received between Sep 12, 2019 and Jan 26, 2023 — classified as 25 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (12 reports).
11 other recalls cover devices cleared under the same FDA submission (K090234); 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.
Most reported problems
Device problems
- Loss of Osseointegration12
- Failure to Osseointegrate10
- Osseointegration Problem3
Patient problems
- Failure of Implant25
- Unspecified Infection6
- Inflammation5
- Pain3
- Insufficient Information2
- No Consequences Or Impact To Patient2
- Fibrosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16250783 ↗InjuryOct 27, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 15681414 ↗InjuryOct 14, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4) , AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15605331 ↗InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 14074540 ↗InjurySep 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12540157 ↗InjurySep 24, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12525531 ↗InjurySep 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12480640 ↗InjuryAug 19, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12342013 ↗InjuryJun 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 12091980 ↗InjuryFeb 16, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 11332144 ↗InjuryFeb 16, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 11332125 ↗InjuryFeb 12, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11321460 ↗InjuryDec 9, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 10973678 ↗InjurySep 19, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 10557730 ↗InjurySep 19, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 10557728 ↗InjuryApr 17, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 9971704 ↗InjuryJan 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9646111 ↗InjuryJan 14, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Organ Dehiscence
MAUDE report 9585524 ↗InjuryDec 26, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 9518259 ↗InjuryNov 29, 2019Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9390929 ↗InjuryNov 14, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 9320289 ↗InjuryOct 31, 2019Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9259633 ↗InjuryOct 18, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 9207891 ↗InjurySep 27, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 9129163 ↗InjurySep 12, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9003552 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090234. One submission often covers many models, so check the product and lot details in each record.
- Z-1157-2020 · Oct 11, 2019 · TerminatedImplant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
- Z-1041-2020 · Oct 7, 2019 · TerminatedLegacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
- Z-0364-2020 · Aug 9, 2019 · TerminatedImplant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
- Z-0018-2020 · Aug 8, 2018 · TerminatedImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The re
- Z-1167-2018 · Jan 19, 2018 · TerminatedSwishTapered Implant Intended for use in support for fixed bridgework.
- Z-0185-2018 · Oct 10, 2017 · TerminatedImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for
- Z-0007-2018 · Jul 21, 2017 · TerminatedImplant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Z-1112-2017 · Dec 12, 2016 · TerminatedSwishTapered Implant
- Z-0961-2017 · Nov 28, 2016 · TerminatedGoDirect Screw-Retaining Top Part Numbers: 4500-61
- Z-1920-2018 · Nov 15, 2016 · TerminatedImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
- Z-1267-2016 · Mar 4, 2016 · TerminatedThe Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Numbe
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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