simply Legacy™2 Implant 823211URecalls & 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 dental implant has 94 reports, 91 of them injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone, and some describe parts fracturing or not being firm enough at placement. Reports rose from 8 in the prior 12 months to 14 in the latest 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
- 94
- Deaths reported
- 0
- Injuries reported
- 91
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10841307107316), received between Jun 19, 2018 and May 27, 2026 — classified as 91 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (59 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 Osseointegrate59
- Positioning Failure7
- Fracture6
- Loss of Osseointegration5
- Osseointegration Problem5
- Adverse Event Without Identified Device or Use Problem3
- Device-Device Incompatibility2
- Malposition of Device2
Patient problems
- Failure of Implant68
- Inadequate Osseointegration20
- No Clinical Signs, Symptoms or Conditions17
- Inflammation12
- Osteopenia/ Osteoporosis12
- Unspecified Infection9
- No Consequences Or Impact To Patient8
- Pain7
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25306973 ↗InjuryMay 11, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25138857 ↗InjuryMay 11, 2026Failure to Osseointegrate
PART NOT RETURNED.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25137982 ↗InjuryMay 1, 2026Fracture
InjuryApr 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24900144 ↗InjuryFeb 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24283675 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23928107 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840061 ↗InjuryDec 10, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769063 ↗InjuryDec 10, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768897 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL COMPLICATION ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23483672 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474395 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474328 ↗InjuryNov 4, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IMPLANT/ABUTMENT SHINES THROUGH RESTORATION.
Patient problems: Failure of Implant
MAUDE report 23461137 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23436408 ↗InjuryMar 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21612469 ↗InjuryMar 6, 2025Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
FAILURE OF OSSEOINTEGRATION
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21541118 ↗InjuryJan 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21184088 ↗InjuryJan 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21184084 ↗InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 21173611 ↗InjuryNov 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 20605516 ↗InjuryOct 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20347490 ↗InjuryAug 7, 2024Positioning Failure; Failure to Osseointegrate; Positioning Failure; Failure to Osseointegrate
CUSTOMER STATES, "FAILURE TO OSSEOINTEGRATE". CUSTOMER CLAIM, INDICATES LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19930319 ↗InjuryJun 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
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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