SIMPLY ICONIC 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
- 2,189
- Deaths reported
- 0
- Injuries reported
- 2,179
- Recalls
- 0
We found 39 models of SIMPLY ICONIC Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 2,189 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2022 and Sep 30, 2026 — classified as 2,179 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,305 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 ICONIC Implant problems
Device problems
- Failure to Osseointegrate1,305
- Positioning Failure421
- Osseointegration Problem164
- Malposition of Device131
- Premature Separation63
- Loss of Osseointegration46
- Labelling, Instructions for Use or Training Problem38
- Difficult to Insert36
Patient problems
- No Clinical Signs, Symptoms or Conditions1,336
- Inadequate Osseointegration1,274
- Failure of Implant436
- Unspecified Infection153
- Inflammation108
- Abscess96
- Pain47
- Osteopenia/ Osteoporosis44
SIMPLY ICONIC Implant models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Simply Iconic™ Implant 674210NPImplant, Endosseous, Root-Form183 reports
- Simply Iconic™ Implant 673710NPImplant, Endosseous, Root-Form181 reports
- SIMPLY ICONIC™ Implant 674710RPImplant, Endosseous, Root-Form141 reports
- Simply Iconic™ Implant 673711NPImplant, Endosseous, Root-Form131 reports
- SIMPLY ICONIC™ Implant 675210RPImplant, Endosseous, Root-Form130 reports
- Simply Iconic™ Implant 674211NPImplant, Endosseous, Root-Form123 reports
- SIMPLY ICONIC™ Implant 675208RPImplant, Endosseous, Root-Form108 reports
- Simply Iconic™ Implant 673713NPImplant, Endosseous, Root-Form98 reports
- Simply Iconic™ Implant 674208NPImplant, Endosseous, Root-Form95 reports
- Simply Iconic™ Implant 673210NPImplant, Endosseous, Root-Form90 reports
- SIMPLY ICONIC™ Implant 674213NPImplant, Endosseous, Root-Form83 reports
- SIMPLY ICONIC™ Implant 674711RPImplant, Endosseous, Root-Form79 reports
- SIMPLY ICONIC™ Implant 674708RPImplant, Endosseous, Root-Form77 reports
- SIMPLY ICONIC™ Implant 674710NPImplant, Endosseous, Root-Form71 reports
- Simply Iconic™ Implant 673211NPImplant, Endosseous, Root-Form68 reports
- SIMPLY ICONIC™ Implant 675710RPImplant, Endosseous, Root-Form60 reports
- Simply Iconic™ Implant 673708NPImplant, Endosseous, Root-Form50 reports
- Simply Iconic™ Implant 673213NPImplant, Endosseous, Root-Form45 reports
- SIMPLY ICONIC™ Implant 675211RPImplant, Endosseous, Root-Form43 reports
- SIMPLY ICONIC™ Implant 675708RPImplant, Endosseous, Root-Form41 reports
- SIMPLY ICONIC™ Implant 674708NPImplant, Endosseous, Root-Form37 reports
- Simply Iconic™ Implant 673208NPImplant, Endosseous, Root-Form31 reports
- SIMPLY ICONIC™ Implant 675206RPImplant, Endosseous, Root-Form25 reports
- Simply Iconic™ Implant 673716NPImplant, Endosseous, Root-Form24 reports
- Simply Iconic™ Implant 674206NPImplant, Endosseous, Root-Form23 reports
- SIMPLY ICONIC™ Implant 674711NPImplant, Endosseous, Root-Form20 reports
- SIMPLY ICONIC™ Implant 674713RPImplant, Endosseous, Root-Form18 reports
- SIMPLY ICONIC™ Implant 675711RPImplant, Endosseous, Root-Form18 reports
- SIMPLY ICONIC™ Implant 674216NPImplant, Endosseous, Root-Form17 reports
- SIMPLY ICONIC™ Implant 674713NPImplant, Endosseous, Root-Form17 reports
- SIMPLY ICONIC™ Implant 675213RPImplant, Endosseous, Root-Form14 reports
- SIMPLY ICONIC™ Implant 675706RPImplant, Endosseous, Root-Form9 reports
- Simply Iconic™ Implant 673216NPImplant, Endosseous, Root-Form8 reports
- SIMPLY ICONIC™ Implant 674706NPImplant, Endosseous, Root-Form7 reports
- Simply Iconic™ Implant 673706NPImplant, Endosseous, Root-Form6 reports
- SIMPLY ICONIC™ Implant 674706RPImplant, Endosseous, Root-Form6 reports
- SIMPLY ICONIC™ Implant 675713RPImplant, Endosseous, Root-Form6 reports
- SIMPLY ICONIC™ Implant 674716NPImplant, Endosseous, Root-Form4 reports
- SIMPLY ICONIC™ Implant 674716RPImplant, Endosseous, Root-Form2 reports
Recent SIMPLY ICONIC 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
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50952926 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 50949918 ↗InjurySep 29, 2026Positioning Failure; Osseointegration Problem
Patient problems: Inadequate Osseointegration
MAUDE report 50938966 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50938936 ↗InjurySep 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50937356 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937049 ↗InjurySep 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50936512 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936143 ↗InjurySep 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50935745 ↗InjurySep 29, 2026Difficult to Insert
Part/Interface does not engage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935639 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50921873 ↗InjurySep 28, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50916355 ↗InjurySep 28, 2026Premature Separation
Part not retained on mating Part.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916193 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50832772 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50832768 ↗
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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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