simply Legacy3 ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,402
- Deaths reported
- 1
- Injuries reported
- 1,378
- Recalls
- 0
We found 39 models of simply Legacy3 Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 1,402 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2018 and Sep 29, 2026 — classified as 1 death, 1,378 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (859 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported simply Legacy3 Implant problems
Device problems
- Failure to Osseointegrate859
- Positioning Failure147
- Loss of Osseointegration97
- Osseointegration Problem92
- Positioning Problem74
- Difficult to Insert24
- Adverse Event Without Identified Device or Use Problem19
- Separation Failure17
Patient problems
- Failure of Implant1,124
- Osteopenia/ Osteoporosis214
- No Clinical Signs, Symptoms or Conditions210
- Inadequate Osseointegration200
- Unspecified Infection159
- Inflammation142
- Pain124
- No Consequences Or Impact To Patient112
simply Legacy3 Implant models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- simply Legacy™3 Implant 853710UImplant, Endosseous, Root-Form153 reports
- simply Legacy™3 Implant 854710UImplant, Endosseous, Root-Form134 reports
- simply Legacy™3 Implant 854210UImplant, Endosseous, Root-Form117 reports
- simply Legacy™3 Implant 853711UImplant, Endosseous, Root-Form91 reports
- simply Legacy™3 Implant 854211UImplant, Endosseous, Root-Form74 reports
- simply Legacy™3 Implant 853210UImplant, Endosseous, Root-Form70 reports
- simply Legacy™3 Implant 854708UImplant, Endosseous, Root-Form1 death62 reports
- simply Legacy™3 Implant 853713UImplant, Endosseous, Root-Form57 reports
- simply Legacy™3 Implant 853708UImplant, Endosseous, Root-Form53 reports
- simply Legacy™3 Implant 854208UImplant, Endosseous, Root-Form53 reports
- simply Legacy™3 Implant 854711UImplant, Endosseous, Root-Form51 reports
- simply Legacy™3 Implant 855210UImplant, Endosseous, Root-Form45 reports
- simply Legacy™3 Implant 853211UImplant, Endosseous, Root-Form40 reports
- simply Legacy™3 Implant 855710UImplant, Endosseous, Root-Form37 reports
- simply Legacy™3 Implant 853208UImplant, Endosseous, Root-Form34 reports
- simply Legacy™3 Implant 854713UImplant, Endosseous, Root-Form34 reports
- simply Legacy™3 Implant 853213UImplant, Endosseous, Root-Form31 reports
- simply Legacy™3 Implant 853706UImplant, Endosseous, Root-Form29 reports
- simply Legacy™3 Implant 854213UImplant, Endosseous, Root-Form28 reports
- simply Legacy™3 Implant 854706UImplant, Endosseous, Root-Form25 reports
- simply Legacy™3 Implant 855708UImplant, Endosseous, Root-Form25 reports
- simply Legacy™3 Implant 855208UImplant, Endosseous, Root-Form24 reports
- simply Legacy™3 Implant 855706UImplant, Endosseous, Root-Form19 reports
- simply Legacy™3 Implant 854206UImplant, Endosseous, Root-Form18 reports
- simply Legacy™3 Implant 855711UImplant, Endosseous, Root-Form15 reports
- simply Legacy™3 Implant 853716UImplant, Endosseous, Root-Form14 reports
- simply Legacy™3 Implant 855206UImplant, Endosseous, Root-Form12 reports
- simply Legacy™3 Implant 855211UImplant, Endosseous, Root-Form10 reports
- simply Legacy™3 Implant 857008UImplant, Endosseous, Root-Form9 reports
- simply Legacy™3 Implant 855213UImplant, Endosseous, Root-Form7 reports
- simply Legacy™3 Implant 853216UImplant, Endosseous, Root-Form6 reports
- simply Legacy™3 Implant 857010UImplant, Endosseous, Root-Form6 reports
- simply Legacy™3 Implant 854716UImplant, Endosseous, Root-Form5 reports
- simply Legacy™3 Implant 855713UImplant, Endosseous, Root-Form5 reports
- simply Legacy™3 Implant 857006UImplant, Endosseous, Root-Form3 reports
- simply Legacy™3 Implant 854216UImplant, Endosseous, Root-Form2 reports
- simply Legacy™3 Implant 855716UImplant, Endosseous, Root-Form2 reports
- simply Legacy™3 Implant 855216UImplant, Endosseous, Root-Form1 report
- simply Legacy™3 Implant 857011UImplant, Endosseous, Root-Form1 report
Recent simply Legacy3 Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Migration
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50832771 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484015 ↗InjuryAug 20, 2026Failure to Osseointegrate
Lack of stability during placement.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50358870 ↗InjuryAug 17, 2026Positioning Failure; Inadequacy of Device Shape and/or Size
Implant/Abutment partially visible.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50282461 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50214680 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50203178 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50202786 ↗InjuryJul 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 50091404 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50020445 ↗InjuryJun 4, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25403085 ↗InjuryJun 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25403061 ↗InjuryMay 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25305316 ↗InjuryMay 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Inadequate Osseointegration
MAUDE report 25285781 ↗InjuryMay 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Granuloma; Inadequate Osseointegration
MAUDE report 25285522 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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