simply Legacy™2 Implant 824211URecalls & 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 2 is a dental implant placed in the jawbone to hold a replacement tooth. Its 240 reports mostly describe the implant failing to fuse with the jawbone, and some describe infection around it. The reports include 238 injuries and no deaths, and they rose from 18 in the prior 12 months to 41 in the last 12 months. 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
- 238
- Deaths reported
- 0
- Injuries reported
- 236
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 238 adverse event reports that list this exact device (DI 10841307107415), received between Aug 17, 2019 and Sep 14, 2026 — classified as 236 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (127 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 Osseointegrate127
- Positioning Failure40
- Osseointegration Problem29
- Loss of Osseointegration17
- Positioning Problem8
- Malposition of Device7
- Adverse Event Without Identified Device or Use Problem4
- Migration3
Patient problems
- Failure of Implant166
- No Clinical Signs, Symptoms or Conditions54
- Inadequate Osseointegration46
- Unspecified Infection42
- Osteopenia/ Osteoporosis36
- Inflammation30
- Granuloma18
- Pain18
Recent adverse event reports
The 25 most recent of 238 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50754137 ↗InjuryAug 17, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288380 ↗InjuryAug 17, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288094 ↗InjuryJul 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 50090951 ↗InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25797936 ↗InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25692362 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25629865 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25163480 ↗InjuryApr 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24903631 ↗InjuryApr 16, 2026Migration
InjuryApr 16, 2026Malposition of Device
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897404 ↗InjuryApr 14, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24877983 ↗InjuryApr 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24863613 ↗InjuryApr 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24806580 ↗InjuryApr 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24779927 ↗InjuryMar 19, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 24644506 ↗InjuryFeb 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24403270 ↗InjuryJan 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24199948 ↗InjuryJan 27, 2026Premature Separation
DROPPED FROM IMPLANT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193402 ↗InjuryJan 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Granuloma; Inadequate Osseointegration; Unspecified Infection
MAUDE report 24161095 ↗InjuryJan 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23968272 ↗InjuryJan 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23968248 ↗InjuryDec 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23928103 ↗InjuryDec 24, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23889706 ↗InjuryDec 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23854066 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page