Legacy™1 Implant 804711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.7 x 11.5 Platform 4.5mmD · Class 2 · Implant
All models of Legacy1 Implant (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct Legacy 1 endosseous root-form dental implant is a screw-shaped titanium fixture placed in the jaw to support a tooth. Most of the 75 reports describe the implant failing to fuse with the surrounding bone, so it later loosens or has to be removed, along with pain, swelling, and some reports of infection or bone loss. No deaths were reported. There are no recalls naming 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
- 75
- Deaths reported
- 0
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10841307100904), received between Oct 25, 2018 and Nov 4, 2025 — classified as 75 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (52 reports).
4 other recalls cover devices cleared under the same FDA submission (K061319); 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 Osseointegrate52
- Loss of Osseointegration12
- Osseointegration Problem6
- Positioning Failure2
- Device Appears to Trigger Rejection1
- Fracture1
- Patient Device Interaction Problem1
- Positioning Problem1
Patient problems
- Failure of Implant70
- Pain27
- Osteopenia/ Osteoporosis22
- Inflammation16
- Unspecified Infection11
- Edema8
- No Consequences Or Impact To Patient8
- Granuloma7
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462836 ↗InjuryJan 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 21233900 ↗InjuryJun 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19561441 ↗InjuryMar 4, 2024Premature Separation; Premature Separation
InjuryJul 24, 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 17378304 ↗InjuryMay 26, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BONE FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 17010018 ↗InjuryMay 26, 2023Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Granuloma; Inflammation; Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 17010012 ↗InjuryMay 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; Fibrosis; Granuloma; Pain
MAUDE report 16994871 ↗InjuryFeb 2, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILIT.Y
Patient problems: Failure of Implant; Numbness; Osteopenia/ Osteoporosis; Sensitivity of Teeth
MAUDE report 16282228 ↗InjuryNov 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4) , AFTER CLINICAL PROCEDURE, BONE FRACTURE WAS OBSERVED.
Patient problems: Bone Fracture(s); Failure of Implant; Pain
MAUDE report 15891183 ↗InjurySep 26, 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; Granuloma
MAUDE report 15483962 ↗InjuryAug 24, 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; Inflammation
MAUDE report 15282954 ↗InjuryAug 2, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 15146476 ↗InjuryJul 5, 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; Granuloma; Inflammation; Unspecified Infection
MAUDE report 14915721 ↗InjuryJul 5, 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; Granuloma; Inflammation; Unspecified Infection
MAUDE report 14915649 ↗InjuryApr 28, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 14239261 ↗InjuryApr 26, 2022Osseointegration 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 14199609 ↗InjuryMar 23, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Osteopenia/ Osteoporosis
MAUDE report 13869506 ↗InjuryMar 23, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 13860838 ↗InjuryNov 17, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 12828745 ↗InjuryNov 17, 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; Inflammation
MAUDE report 12828727 ↗InjuryAug 31, 2021Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 12391032 ↗InjuryAug 18, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4) , AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 12336414 ↗InjuryJul 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 12158741 ↗InjuryJun 3, 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; Granuloma
MAUDE report 11927410 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061319. One submission often covers many models, so check the product and lot details in each record.
- Z-0010-2020 · Aug 7, 2018 · TerminatedImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousa
- Z-2376-2018 · May 18, 2018 · TerminatedREPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Z-2125-2017 · May 2, 2017 · TerminatedLegacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
- Z-2320-2016 · Jul 5, 2016 · TerminatedRePlant Angled Abutment Part Number 6050-52-60
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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