Legacy™4 Implant 873211Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.2 x 11.5 Platform 3.0mmD · Class 2 · Implant
All models of Legacy4 Implant (58)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct Legacy 4 dental implant is a root-form screw placed into the jawbone to support a tooth replacement. The 51 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that fusion later, along with a few cases where it was positioned incorrectly or the wrong part was used. All 51 reports describe injuries, and no deaths were reported. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10841307102809), received between Mar 22, 2018 and Mar 4, 2026 — classified as 51 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (30 reports).
2 other recalls cover devices cleared under the same FDA submission (K192221); 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
Most reported problems
Device problems
- Failure to Osseointegrate30
- Osseointegration Problem11
- Improper or Incorrect Procedure or Method2
- Loss of Osseointegration2
- Positioning Failure2
- Positioning Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Slipped1
Patient problems
- Failure of Implant42
- Inadequate Osseointegration8
- Granuloma6
- No Clinical Signs, Symptoms or Conditions6
- Unspecified Infection6
- Osteopenia/ Osteoporosis5
- Inflammation4
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24512169 ↗InjuryDec 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23737151 ↗InjuryJan 28, 2025Positioning Problem; Positioning Problem
USABILITY ¿ WRONG PART USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21258251 ↗InjuryDec 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20896805 ↗InjuryAug 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 19954935 ↗InjuryAug 3, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 19901993 ↗InjuryJun 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19452929 ↗InjuryJun 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19452925 ↗InjuryApr 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fistula; Inadequate Osseointegration
MAUDE report 19045018 ↗InjuryFeb 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IMPLANT/ABUTMENT SHINES THROUGH RESTORATION.
Patient problems: Failure of Implant
MAUDE report 18634437 ↗InjuryFeb 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem
PROBLEM WITH OSSEOINTEGRATION.
Patient problems: Failure of Implant; Granuloma
MAUDE report 18520517 ↗InjuryJan 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 4, 2023Failure to Osseointegrate; Failure to Osseointegrate
LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18259172 ↗InjuryOct 20, 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 17976040 ↗InjuryAug 23, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 17602154 ↗InjuryAug 8, 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; Granuloma
MAUDE report 17479310 ↗InjuryJun 30, 2023Device Slipped; Device Slipped
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DROPPED FROM THE IMPLANT DRIVER.
Patient problems: Failure of Implant
MAUDE report 17237284 ↗InjuryJun 30, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Inflammation; Wound Dehiscence
MAUDE report 17237278 ↗InjuryJun 29, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Hypersensitivity/Allergic reaction; Numbness
MAUDE report 17227058 ↗InjuryJun 29, 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 17227051 ↗InjuryFeb 23, 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 16426626 ↗InjuryOct 19, 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; Insufficient Information
MAUDE report 15636644 ↗InjuryOct 11, 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
MAUDE report 15576409 ↗InjuryOct 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4) AFTER CLINICAL PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 15574415 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192221. One submission often covers many models, so check the product and lot details in each record.
- Z-0198-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- Z-0197-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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