Legacy1 ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,635
- Deaths reported
- 0
- Injuries reported
- 1,618
- Recalls
- 0
We found 27 models of Legacy1 Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 1,635 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2017 and Aug 19, 2026 — classified as 1,618 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,053 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 Legacy1 Implant problems
Device problems
- Failure to Osseointegrate1,053
- Loss of Osseointegration195
- Osseointegration Problem162
- Positioning Problem68
- Positioning Failure66
- Fracture31
- Adverse Event Without Identified Device or Use Problem10
- Inadequacy of Device Shape and/or Size8
Patient problems
- Failure of Implant1,514
- Osteopenia/ Osteoporosis440
- Pain429
- Inflammation255
- Unspecified Infection215
- No Consequences Or Impact To Patient175
- Inadequate Osseointegration99
- Fibrosis93
Legacy1 Implant models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Legacy™1 Implant 803710Implant, Endosseous, Root-Form338 reports
- Legacy™1 Implant 803711Implant, Endosseous, Root-Form200 reports
- Legacy™1 Implant 804710Implant, Endosseous, Root-Form178 reports
- Legacy™1 Implant 803713Implant, Endosseous, Root-Form128 reports
- Legacy™1 Implant 804210Implant, Endosseous, Root-Form127 reports
- Legacy™1 Implant 804211Implant, Endosseous, Root-Form127 reports
- Legacy™1 Implant 803708Implant, Endosseous, Root-Form107 reports
- Legacy™1 Implant 804708Implant, Endosseous, Root-Form80 reports
- Legacy™1 Implant 804711Implant, Endosseous, Root-Form75 reports
- Legacy™1 Implant 804208Implant, Endosseous, Root-Form63 reports
- Legacy™1 Implant 804713Implant, Endosseous, Root-Form61 reports
- Legacy™1 Implant 804213Implant, Endosseous, Root-Form42 reports
- Legacy™1 Implant 805708Implant, Endosseous, Root-Form21 reports
- Legacy™1 Implant 805710Implant, Endosseous, Root-Form21 reports
- Legacy™1 Implant 803716Implant, Endosseous, Root-Form20 reports
- Legacy™1 Implant 805711Implant, Endosseous, Root-Form11 reports
- Legacy™1 Implant 804716Implant, Endosseous, Root-Form8 reports
- Legacy™1 Implant 804216Implant, Endosseous, Root-Form6 reports
- Legacy™1 Implant 805713Implant, Endosseous, Root-Form4 reports
- Legacy™1 Implant 815708Implant, Endosseous, Root-Form4 reports
- Legacy™1 Implant 814213Implant, Endosseous, Root-Form3 reports
- Legacy™1 Implant 814710Implant, Endosseous, Root-Form3 reports
- Legacy™1 Implant 814211Implant, Endosseous, Root-Form2 reports
- Legacy™1 Implant 814711Implant, Endosseous, Root-Form2 reports
- Legacy™1 Implant 814713Implant, Endosseous, Root-Form2 reports
- Legacy™1 Implant 813710Implant, Endosseous, Root-Form1 report
- Legacy™1 Implant 814708Implant, Endosseous, Root-Form1 report
Recent Legacy1 Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50333338 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50331893 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50331297 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50214660 ↗InjuryJun 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25600405 ↗InjuryJun 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25586747 ↗InjuryJun 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25461935 ↗InjuryJun 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25461175 ↗InjuryJun 9, 2026Corroded
InjuryJun 9, 2026Material Discolored
DEVICE DE-/DISCOLORATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450615 ↗InjuryMay 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25306755 ↗InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24913148 ↗InjuryApr 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24758985 ↗InjuryMar 23, 2026Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24666190 ↗InjuryMar 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24665370 ↗
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
- InterActive Implant23 models · 1,609 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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