Legacy™3 Implant 853216Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.2 x 16 Platform 3.0mmD · Class 2 · Implant
All models of Legacy3 Implant (75)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct Legacy 3 dental implant is a small screw-shaped titanium post used as a tooth root replacement. The 54 reports mostly describe the implant failing to fuse with the surrounding bone after placement, sometimes with poor initial stability or the implant ending up in the wrong position; all 54 involve injuries and no deaths are reported. Reports date from 2019 to early 2025, with none in the past 12 months, and 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
- 54
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10841307102021), received between Aug 28, 2019 and Jan 24, 2025 — classified as 54 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (32 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate32
- Osseointegration Problem8
- Positioning Problem6
- Loss of Osseointegration4
- Positioning Failure3
- Fracture1
Patient problems
- Failure of Implant53
- No Consequences Or Impact To Patient14
- Osteopenia/ Osteoporosis9
- Impaired Healing7
- Insufficient Information6
- Unspecified Infection4
- Pain3
- Inflammation2
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryJan 24, 2025Osseointegration Problem; Osseointegration Problem
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233888 ↗InjurySep 27, 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 17825209 ↗InjuryAug 18, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17571721 ↗InjuryJun 22, 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; Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 17178861 ↗InjuryMay 2, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 16857511 ↗InjuryMar 3, 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; Osteopenia/ Osteoporosis
MAUDE report 16476092 ↗InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 15904976 ↗InjuryNov 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 15787386 ↗InjuryAug 23, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 15275562 ↗InjuryAug 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 15183804 ↗InjuryMay 7, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14317299 ↗InjuryMar 3, 2022Osseointegration Problem; Osseointegration Problem
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13660137 ↗InjuryFeb 9, 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; Granuloma; Osteopenia/ Osteoporosis
MAUDE report 13498367 ↗InjuryOct 8, 2021Positioning Failure; Positioning Failure
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 12598042 ↗InjurySep 16, 2021Failure 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 12480602 ↗InjuryJun 4, 2021Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11937199 ↗InjuryMay 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), CLAIM FORM RECEIVED WITH MISSING INFORMATION, CONTACTED CUSTOMER FOR ADDITIONAL INFORMATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 11877114 ↗InjuryApr 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11678102 ↗InjuryApr 14, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11664123 ↗InjuryApr 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 11632538 ↗InjuryMar 11, 2021Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FRACTURE OF BONE.
Patient problems: Failure of Implant
MAUDE report 11458487 ↗InjuryFeb 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11330833 ↗InjuryFeb 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11330830 ↗InjuryJan 29, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11250643 ↗InjuryJan 29, 2021Osseointegration Problem; Osseointegration Problem
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11250639 ↗
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 resp
- 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
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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