Legacy™4 Implant 874211Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.2 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 Legacy 4 dental implant is placed in the jawbone to replace a missing tooth root. Reports mostly describe implants that fail to fuse with the jawbone or later lose that bond, along with infection and inflammation. There are 83 reports with no deaths and 79 injuries. No recalls name this device. Reports rose from 2 in the previous 12 months to 12 in the past year.
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
- 83
- Deaths reported
- 0
- Injuries reported
- 79
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10841307102922), received between Nov 20, 2018 and Jun 24, 2026 — classified as 79 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (33 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 Osseointegrate33
- Osseointegration Problem13
- Positioning Failure13
- Loss of Osseointegration12
- Positioning Problem6
- Separation Failure3
- Device Appears to Trigger Rejection1
- Fracture1
Patient problems
- Failure of Implant67
- Osteopenia/ Osteoporosis14
- Inadequate Osseointegration13
- Inflammation12
- Unspecified Infection12
- No Clinical Signs, Symptoms or Conditions10
- Pain9
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 25616552 ↗InjuryApr 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24942698 ↗InjuryApr 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation; Pain
MAUDE report 24811987 ↗InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 23767861 ↗InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23767329 ↗InjuryDec 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23750987 ↗InjuryDec 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23750917 ↗InjuryDec 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23750803 ↗InjuryDec 8, 2025Malposition of Device; Malposition of Device
PRIMARY STABILITY COULDN'T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745893 ↗InjuryDec 8, 2025Positioning Failure; Positioning Failure
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23737017 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474633 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436295 ↗InjuryDec 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20921274 ↗InjuryOct 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20509549 ↗InjuryOct 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Inadequate Osseointegration; Inflammation
MAUDE report 20509514 ↗InjuryOct 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 20362295 ↗InjuryMar 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 17, 2024Positioning Failure; Positioning Failure
InjuryNov 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 18201321 ↗InjuryOct 13, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 17932388 ↗InjuryOct 5, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4),DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17875455 ↗InjurySep 28, 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; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 17837617 ↗InjurySep 21, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17788972 ↗InjuryAug 10, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17498008 ↗
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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