GoDirect ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 207
- Deaths reported
- 0
- Injuries reported
- 201
- Recalls
- 0
We found 30 models of GoDirect Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 207 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2018 and Feb 19, 2026 — classified as 201 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (144 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 GoDirect Implant problems
Device problems
- Failure to Osseointegrate144
- Loss of Osseointegration37
- Osseointegration Problem12
- Positioning Problem4
- Device Appears to Trigger Rejection3
- Material Deformation2
- Separation Failure2
- Break1
Patient problems
- Failure of Implant196
- Pain58
- Osteopenia/ Osteoporosis52
- Inflammation34
- No Consequences Or Impact To Patient34
- Unspecified Infection25
- Granuloma15
- Edema14
GoDirect Implant models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GoDirect® Implant 423010LImplant, Endosseous, Root-Form25 reports
- GoDirect® Implant 423010Implant, Endosseous, Root-Form18 reports
- GoDirect® Implant 423710LImplant, Endosseous, Root-Form17 reports
- GoDirect® Implant 423011LImplant, Endosseous, Root-Form14 reports
- GoDirect® Implant 423013Implant, Endosseous, Root-Form12 reports
- GoDirect® Implant 423011Implant, Endosseous, Root-Form11 reports
- GoDirect® Implant 423713Implant, Endosseous, Root-Form10 reports
- GoDirect® Implant 424713LImplant, Endosseous, Root-Form9 reports
- GoDirect® Implant 423013LImplant, Endosseous, Root-Form8 reports
- GoDirect® Implant 433011LImplant, Endosseous, Root-Form8 reports
- GoDirect® Implant 423711Implant, Endosseous, Root-Form7 reports
- GoDirect® Implant 433010Implant, Endosseous, Root-Form7 reports
- GoDirect® Implant 433010LImplant, Endosseous, Root-Form7 reports
- GoDirect® Implant 433013Implant, Endosseous, Root-Form6 reports
- GoDirect® Implant 423711LImplant, Endosseous, Root-Form6 reports
- GoDirect® Implant 433011Implant, Endosseous, Root-Form5 reports
- GoDirect® Implant 433013LImplant, Endosseous, Root-Form5 reports
- GoDirect® Implant 433711LImplant, Endosseous, Root-Form5 reports
- GoDirect® Implant 423713LImplant, Endosseous, Root-Form4 reports
- GoDirect® Implant 433710LImplant, Endosseous, Root-Form4 reports
- GoDirect® Implant 423710Implant, Endosseous, Root-Form3 reports
- GoDirect® Implant 424710Implant, Endosseous, Root-Form3 reports
- GoDirect® Implant 433711Implant, Endosseous, Root-Form3 reports
- GoDirect® Implant 424708LImplant, Endosseous, Root-Form2 reports
- GoDirect® Implant 424710LImplant, Endosseous, Root-Form2 reports
- GoDirect® Implant 433713LImplant, Endosseous, Root-Form2 reports
- GoDirect® Implant 424708Implant, Endosseous, Root-Form1 report
- GoDirect® Implant 424713Implant, Endosseous, Root-Form1 report
- GoDirect® Implant 433710Implant, Endosseous, Root-Form1 report
- GoDirect® Implant 433713Implant, Endosseous, Root-Form1 report
Recent GoDirect Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24390843 ↗InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21348883 ↗InjuryDec 13, 2024Positioning Failure; Positioning Failure
InjurySep 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Granuloma; Inadequate Osseointegration; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 20304731 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20079019 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20078914 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19963712 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19961904 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19961903 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19961902 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19961899 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19961896 ↗InjuryMar 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 27, 2023Loss of Osseointegration; Loss of Osseointegration
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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