simply Legacy™2 Implant 825208URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of simply Legacy2 Implant (38)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct simply Legacy is a dental implant placed in the jawbone. Its 79 reports, with no deaths and 77 injuries, mostly describe implants that did not bond with the jawbone, and some describe placement problems. Reports rose to 22 in the last 12 months, from 4 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
- 78
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10841307107491), received between Aug 27, 2019 and Sep 30, 2026 — classified as 76 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (43 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 Osseointegrate43
- Positioning Failure11
- Positioning Problem7
- Loss of Osseointegration5
- Osseointegration Problem4
- Insufficient Device Problem Information2
- Premature Separation2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant51
- Inadequate Osseointegration24
- No Clinical Signs, Symptoms or Conditions17
- Inflammation8
- No Consequences Or Impact To Patient8
- Osteopenia/ Osteoporosis7
- Unspecified Infection7
- Fibrosis6
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50952916 ↗InjurySep 15, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50773969 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Fistula; Inadequate Osseointegration
MAUDE report 50485341 ↗InjuryMay 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25323110 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25164747 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25107710 ↗InjuryApr 29, 2026Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034948 ↗InjuryApr 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24993937 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24747887 ↗InjuryJan 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24192621 ↗InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration
MAUDE report 23640347 ↗InjuryNov 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23565778 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483626 ↗InjuryNov 5, 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 23474689 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474605 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474524 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
(B)(4).
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474474 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 23474436 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474304 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474212 ↗InjuryNov 4, 2025Insufficient Device Problem Information; Unclear Information; Insufficient Device Problem Information; Unclear Information
INCORRECT PART USED DUE TO INSUFFICIENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461563 ↗InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23436870 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 23436348 ↗InjuryApr 4, 2025Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21779008 ↗InjuryNov 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20635012 ↗
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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