Legacy™2 Implant 825711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.7 x 11.5 Platform 5.7mmD · Class 2 · Implant
All models of Legacy2 Implant (78)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct Legacy2 Implant is a root-form dental implant used to replace missing teeth. The 70 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that bond after placement, along with difficulty positioning it correctly in the jaw. Sixty-eight reports involved 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
- 70
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10841307101505), received between Aug 9, 2018 and Jul 15, 2026 — classified as 68 injuries, 2 malfunctions.
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
- Loss of Osseointegration15
- Positioning Failure10
- Osseointegration Problem6
- Positioning Problem5
- Separation Failure3
- Connection Problem1
- Difficult to Insert1
Patient problems
- Failure of Implant58
- Inflammation15
- Unspecified Infection13
- No Consequences Or Impact To Patient12
- Osteopenia/ Osteoporosis12
- No Clinical Signs, Symptoms or Conditions10
- Inadequate Osseointegration9
- Pain6
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25830065 ↗InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25829950 ↗InjuryJul 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25829493 ↗InjuryMay 29, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25340401 ↗InjuryApr 14, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24873476 ↗InjuryMar 5, 2026Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24520139 ↗InjuryNov 6, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483641 ↗InjuryFeb 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 21, 2025Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201354 ↗InjuryJan 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21153040 ↗InjuryNov 7, 2024Osseointegration Problem; Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20634798 ↗InjuryAug 24, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20058610 ↗InjuryMay 7, 2024Fracture; Fracture
InjuryApr 25, 2024Positioning Failure; Positioning Failure
COMPL:PRIMARY STABILITY COULDN'T BE ACHI.
Patient problems: Failure of Implant
MAUDE report 19185237 ↗InjuryOct 9, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BONE FRACTURE WAS OBSERVED.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 17895757 ↗InjuryAug 25, 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; Inflammation; Unspecified Infection
MAUDE report 17621992 ↗InjuryAug 14, 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; Granuloma
MAUDE report 17539326 ↗InjuryAug 3, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17451348 ↗InjuryJun 29, 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; Fibrosis; Inflammation; Numbness; Osteopenia/ Osteoporosis; Sensitivity of Teeth; Unspecified Infection
MAUDE report 17227078 ↗InjuryJun 28, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY
Patient problems: Failure of Implant
MAUDE report 17222447 ↗InjuryMar 30, 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 16646468 ↗InjuryMar 10, 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
MAUDE report 16520822 ↗InjuryJan 17, 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 16183860 ↗InjuryDec 19, 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 16007815 ↗InjuryOct 18, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 15626838 ↗
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-0197-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
- Z-0198-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 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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