Legacy™4 Implant 873711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 11.5 Platform 3.5mmD · 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 has 147 FDA adverse event reports, with no deaths and 146 injuries. Most describe the implant failing to fuse with the jawbone, along with some positioning problems and a few fractures. Patient problems include implant failure, bone thinning, inflammation and granulomas. Reports rose to 17 in the latest 12 months compared with 1 in the 12 months before. 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
- 147
- Deaths reported
- 0
- Injuries reported
- 146
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 10841307102861), received between Jan 16, 2019 and May 26, 2026 — classified as 146 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (85 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 Osseointegrate85
- Osseointegration Problem34
- Positioning Failure11
- Loss of Osseointegration8
- Positioning Problem5
- Fracture2
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Failure of Implant126
- Osteopenia/ Osteoporosis24
- Inflammation18
- Inadequate Osseointegration17
- Granuloma14
- Pain13
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient12
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Inadequate Osseointegration
MAUDE report 25286504 ↗InjuryMay 19, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25219906 ↗InjuryApr 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 24791875 ↗InjuryMar 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24657105 ↗InjuryFeb 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24471399 ↗InjuryDec 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23794637 ↗InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Inadequate Osseointegration
MAUDE report 23767623 ↗InjuryDec 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Granuloma; Inflammation
MAUDE report 23758251 ↗InjuryDec 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Granuloma; Inadequate Osseointegration
MAUDE report 23757798 ↗InjuryDec 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23750370 ↗InjuryDec 8, 2025Malposition of Device; Malposition of Device
PRIMARY STABILITY COULDN'T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742437 ↗InjuryDec 8, 2025Osseointegration Problem; Osseointegration Problem
OSSEOINTEGRATION PROBLEM.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 23739079 ↗InjuryNov 6, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483601 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474632 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23463090 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23449278 ↗InjuryDec 11, 2024Separation Problem; Separation Problem
PART NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20907442 ↗InjuryOct 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20509518 ↗InjurySep 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20138575 ↗InjuryAug 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 19950453 ↗InjuryMay 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE OF INTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19348235 ↗InjuryJan 18, 2024Positioning Failure; Positioning Failure
InjuryJan 17, 2024Positioning Failure; Positioning Failure
InjuryOct 24, 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 17993900 ↗
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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