NobelActive® TiUltra™ 300243Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ 3.0 3.0x15mm · Class 2 · Implant
All models of NobelActive TiUltra (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive dental implant is placed in the jawbone to hold a replacement tooth. Its 216 reports include 209 injuries and no deaths. Most reports describe the implant failing to fuse with the jawbone or losing that bond over time, and some describe it lacking stability during placement. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 216
- Deaths reported
- 0
- Injuries reported
- 209
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 216 adverse event reports that list this exact device (DI 07332747127348), received between Nov 9, 2021 and Aug 7, 2026 — classified as 209 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (166 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate166
- Osseointegration Problem16
- Adverse Event Without Identified Device or Use Problem10
- Loss of Osseointegration8
- Insufficient Device Problem Information4
- Migration4
- Premature Separation4
- Activation, Positioning or Separation Problem2
Patient problems
- Failure of Implant150
- No Clinical Signs, Symptoms or Conditions44
- Unspecified Infection14
- Pain10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Foreign Body In Patient4
- Abscess2
- Fistula2
Recent adverse event reports
The 25 most recent of 216 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110894 ↗InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110892 ↗InjuryJun 4, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25401178 ↗InjuryJun 4, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25401171 ↗InjuryJun 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25400988 ↗InjuryJun 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25400963 ↗InjuryMay 3, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063795 ↗InjuryMay 3, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063789 ↗InjuryMar 14, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24601128 ↗InjuryMar 14, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24601127 ↗InjuryMar 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541367 ↗InjuryMar 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540239 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Failure to Osseointegrate
InjuryFeb 16, 2026Failure to Osseointegrate
InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24351304 ↗InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24351301 ↗InjuryJan 27, 2026Failure to Osseointegrate
InjuryJan 27, 2026Failure to Osseointegrate
InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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