NobelActive S TiUniteRecalls & reported problems across all models
Nobel Biocare AB · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls
- 0
We found 12 models of NobelActive S TiUnite by Nobel Biocare AB in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2026 and Sep 17, 2026 — classified as 60 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (38 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 NobelActive S TiUnite problems
Device problems
- Failure to Osseointegrate38
- Osseointegration Problem21
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Unspecified Infection8
- Inflammation4
- Abscess2
- Implant Pain2
- Numbness2
NobelActive S TiUnite models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NobelActive® S TiUnite® 302351Implant, endosseous, root-form10 reports
- NobelActive® S TiUnite® 302344Implant, endosseous, root-form8 reports
- NobelActive® S TiUnite® 302346Implant, endosseous, root-form8 reports
- NobelActive® S TiUnite® 302349Implant, endosseous, root-form8 reports
- NobelActive® S TiUnite® 302350Implant, endosseous, root-form7 reports
- NobelActive® S TiUnite® 302343Implant, endosseous, root-form6 reports
- NobelActive® S TiUnite® 302348Implant, endosseous, root-form4 reports
- NobelActive® S TiUnite® 302345Implant, endosseous, root-form2 reports
- NobelActive® S TiUnite® 302354Implant, endosseous, root-form2 reports
- NobelActive® S TiUnite® 302356Implant, endosseous, root-form2 reports
- NobelActive® S TiUnite® 302362Implant, endosseous, root-form2 reports
- NobelActive® S TiUnite® 302352Implant, endosseous, root-form1 report
Recent NobelActive S TiUnite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811376 ↗InjurySep 17, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811371 ↗InjurySep 17, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811353 ↗InjurySep 17, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811351 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Numbness
MAUDE report 50723053 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Numbness
MAUDE report 50723051 ↗InjurySep 9, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699782 ↗InjurySep 9, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699780 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678043 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678042 ↗InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 26, 2026Failure to Osseointegrate
InjuryAug 26, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50463083 ↗InjuryAug 21, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382462 ↗
Other Nobel Biocare AB products
- NobelActive56 models · 152,066 reports
- NobelReplace120 models · 138,221 reports · 15 recalls
- NobelParallel54 models · 132,525 reports
- NobelActive TiUltra28 models · 82,969 reports
- NobelParallel Conical Connection TiUltra27 models · 68,868 reports
- Replace Select107 models · 33,616 reports
- NobelReplace Conical Connection TiUltra15 models · 31,165 reports
- NobelSpeedy88 models · 24,246 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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