Legacy3 ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 75 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9,801
- Deaths reported
- 0
- Injuries reported
- 9,669
- Recalls
- 0
We found 75 models of Legacy3 Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 9,801 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2017 and Sep 30, 2026 — classified as 9,669 injuries, 132 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5,464 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 Legacy3 Implant problems
Device problems
- Failure to Osseointegrate5,464
- Loss of Osseointegration1,663
- Osseointegration Problem770
- Positioning Failure766
- Positioning Problem577
- Fracture183
- Separation Failure71
- Adverse Event Without Identified Device or Use Problem70
Patient problems
- Failure of Implant8,717
- Osteopenia/ Osteoporosis2,016
- Pain1,507
- Unspecified Infection1,377
- No Consequences Or Impact To Patient1,099
- Inflammation1,060
- No Clinical Signs, Symptoms or Conditions804
- Inadequate Osseointegration784
Legacy3 Implant models
75 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Legacy™3 Implant 853710Implant, Endosseous, Root-Form1,106 reports
- Legacy™3 Implant 854710Implant, Endosseous, Root-Form815 reports
- Legacy™3 Implant 853711Implant, Endosseous, Root-Form758 reports
- Legacy™3 Implant 854210Implant, Endosseous, Root-Form715 reports
- Legacy™3 Implant 853210Implant, Endosseous, Root-Form505 reports
- Legacy™3 Implant 854211Implant, Endosseous, Root-Form475 reports
- Legacy™3 Implant 853713Implant, Endosseous, Root-Form461 reports
- Legacy™3 Implant 854708Implant, Endosseous, Root-Form428 reports
- Legacy™3 Implant 853211Implant, Endosseous, Root-Form407 reports
- Legacy™3 Implant 854711Implant, Endosseous, Root-Form403 reports
- Legacy™3 Implant 853708Implant, Endosseous, Root-Form378 reports
- Legacy™3 Implant 855210Implant, Endosseous, Root-Form340 reports
- Legacy™3 Implant 854208Implant, Endosseous, Root-Form300 reports
- Legacy™3 Implant 853213Implant, Endosseous, Root-Form282 reports
- Legacy™3 Implant 854213Implant, Endosseous, Root-Form238 reports
- Legacy™3 Implant 853208Implant, Endosseous, Root-Form224 reports
- Legacy™3 Implant 854713Implant, Endosseous, Root-Form186 reports
- Legacy™3 Implant 855208Implant, Endosseous, Root-Form177 reports
- Legacy™3 Implant 855710Implant, Endosseous, Root-Form177 reports
- Legacy™3 Implant 855211Implant, Endosseous, Root-Form149 reports
- Legacy™3 Implant 855708Implant, Endosseous, Root-Form125 reports
- Legacy™3 Implant 855711Implant, Endosseous, Root-Form99 reports
- 69 reports
- Legacy™3 Implant 855213Implant, Endosseous, Root-Form69 reports
- Legacy™3 Implant 857010Implant, Endosseous, Root-Form68 reports
- Legacy™3 Implant 853716Implant, Endosseous, Root-Form62 reports
- 58 reports
- Legacy™3 Implant 853216Implant, Endosseous, Root-Form54 reports
- 43 reports
- Legacy™3 Implant 857011Implant, Endosseous, Root-Form43 reports
- Legacy™3 Implant 857008Implant, Endosseous, Root-Form40 reports
- Legacy™3 Implant 855713Implant, Endosseous, Root-Form38 reports
- Legacy™3 Implant 864710Implant, Endosseous, Root-Form36 reports
- 32 reports
- 31 reports
- Legacy™3 Implant 854716Implant, Endosseous, Root-Form28 reports
- Legacy™3 Implant 854216Implant, Endosseous, Root-Form25 reports
- Legacy™3 Implant 864210Implant, Endosseous, Root-Form25 reports
- Legacy™3 Implant 863711Implant, Endosseous, Root-Form24 reports
- Legacy™3 Implant 863710Implant, Endosseous, Root-Form23 reports
- Legacy™3 Implant 864211Implant, Endosseous, Root-Form23 reports
- Legacy™3 Implant 864711Implant, Endosseous, Root-Form19 reports
- Legacy™3 Implant 864213Implant, Endosseous, Root-Form18 reports
- Legacy™3 Implant 863708Implant, Endosseous, Root-Form14 reports
- Legacy™3 Implant 864713Implant, Endosseous, Root-Form14 reports
- Legacy™3 Implant 865210Implant, Endosseous, Root-Form14 reports
- Legacy™3 Implant 855216Implant, Endosseous, Root-Form13 reports
- Legacy™3 Implant 857013Implant, Endosseous, Root-Form13 reports
- Legacy™3 Implant 864708Implant, Endosseous, Root-Form13 reports
- Legacy™3 Implant 855716Implant, Endosseous, Root-Form11 reports
- 11 reports
- Legacy™3 Implant 863210Implant, Endosseous, Root-Form10 reports
- Legacy™3 Implant 863713Implant, Endosseous, Root-Form10 reports
- Legacy™3 Implant 865710Implant, Endosseous, Root-Form10 reports
- Legacy™3 Implant 863208Implant, Endosseous, Root-Form8 reports
- Legacy™3 Implant 864208Implant, Endosseous, Root-Form8 reports
- Legacy™3 Implant 865213Implant, Endosseous, Root-Form8 reports
- Legacy™3 Implant 863213Implant, Endosseous, Root-Form7 reports
- Legacy™3 Implant 865208Implant, Endosseous, Root-Form7 reports
- 7 reports
- Legacy™3 Implant 863211Implant, Endosseous, Root-Form6 reports
- Legacy™3 Implant 865708Implant, Endosseous, Root-Form6 reports
- Legacy™3 Implant 865711Implant, Endosseous, Root-Form6 reports
- Legacy™3 Implant 865713Implant, Endosseous, Root-Form6 reports
- 5 reports
- Legacy™3 Implant 865211Implant, Endosseous, Root-Form4 reports
- Legacy™3 Implant 864716Implant, Endosseous, Root-Form3 reports
- Legacy™3 Implant 863716Implant, Endosseous, Root-Form2 reports
- Legacy™3 Implant 864216Implant, Endosseous, Root-Form2 reports
- 2 reports
- 1 report
- Legacy™3 Implant 865716Implant, Endosseous, Root-Form1 report
- Legacy™3 Implant 867008Implant, Endosseous, Root-Form1 report
- Legacy™3 Implant 867010Implant, Endosseous, Root-Form1 report
- Legacy™3 Implant 867011Implant, Endosseous, Root-Form1 report
Recent 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 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50950024 ↗InjurySep 30, 2026Premature Separation
Part not retained on mating Part.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949421 ↗InjurySep 29, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50938952 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50924398 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50832774 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50832769 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50829742 ↗InjurySep 18, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829507 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50780376 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50780375 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780358 ↗InjurySep 15, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50774899 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50741814 ↗InjurySep 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50737029 ↗InjurySep 11, 2026Positioning Failure
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735756 ↗
Other Implant Direct Sybron Manufacturing LLC products
- 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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