simply Legacy™2 Implant 824208URecalls & 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 Simply Legacy 2 implant is an endosseous root-form dental implant. Reports mostly describe it not fusing with bone, lack of stability during placement, and positioning problems. There are 93 reports, no deaths and 92 injuries. No recalls name this device. Reports rose from 6 in the prior 12 months to 13 in the last 12 months.
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
- 94
- Deaths reported
- 0
- Injuries reported
- 93
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10841307107392), received between Sep 11, 2019 and Sep 14, 2026 — classified as 93 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (54 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 Osseointegrate54
- Positioning Failure19
- Loss of Osseointegration5
- Positioning Problem5
- No Apparent Adverse Event3
- Device Slipped2
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant70
- Inadequate Osseointegration20
- No Clinical Signs, Symptoms or Conditions18
- Unspecified Infection14
- Inflammation10
- Osteopenia/ Osteoporosis10
- Fibrosis8
- Pain6
Recent adverse event reports
The 25 most recent of 94 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 50754581 ↗InjuryApr 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Inadequate Osseointegration
MAUDE report 24786955 ↗InjuryMar 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24599593 ↗InjuryFeb 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24337831 ↗InjuryJan 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24132311 ↗InjuryDec 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23937234 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23928113 ↗InjuryDec 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
OSSEOINTEGRATION ISSUE OCCURING WITHIN 3.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23783989 ↗InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23618123 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23487212 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Sinus Perforation
MAUDE report 23474294 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
OSSEOINTEGRATION PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462952 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461430 ↗InjuryNov 4, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461292 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436771 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23415655 ↗MalfunctionMar 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21683595 ↗InjuryMar 24, 2025Failure to Osseointegrate; No Apparent Adverse Event; Failure to Osseointegrate; No Apparent Adverse Event
InjuryFeb 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21289712 ↗InjuryOct 30, 2024Difficult to Insert; Difficult to Insert
InjuryOct 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20456551 ↗InjurySep 25, 2024Malposition of Device; Malposition of Device
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Granuloma; Unspecified Infection
MAUDE report 20304712 ↗InjuryAug 7, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19931735 ↗InjuryJul 2, 2024Positioning Failure; Positioning Failure
COMPL:PRIMARY STABILITY COULDN¿T BE ACHI.
Patient problems: Failure of Implant
MAUDE report 19660325 ↗
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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