Nobel Biocare N1™ 300862Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC RP 4.0x11mm · Class 2 · Implant
All models of Nobel Biocare N1 (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Nobel Biocare N1 dental implant is placed into bone. Most of the 1,250 reports describe the implant failing to bond with the bone, and some mention infection. The reports record 1,236 injuries and no deaths. One recall is open, from January 2025, over a manufacturing issue in which a sharp pin can puncture the blister packaging and break the sterile barrier.
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
- 1,280
- Deaths reported
- 0
- Injuries reported
- 1,266
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,280 adverse event reports that list this exact device (DI 07332747161748), received between Jan 28, 2022 and Sep 30, 2026 — classified as 1,266 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (891 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Jan 10, 2025Class IIOpen, Classified
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Z-1101-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate891
- Loss of Osseointegration212
- Osseointegration Problem74
- Adverse Event Without Identified Device or Use Problem38
- Migration14
- Difficult to Insert11
- Patient Device Interaction Problem10
- Material Deformation8
Patient problems
- Failure of Implant800
- No Clinical Signs, Symptoms or Conditions365
- Unspecified Infection76
- Pain70
- Inflammation22
- Fistula20
- Implant Pain20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
Recent adverse event reports
The 25 most recent of 1,280 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954314 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954311 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940482 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940480 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796335 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796331 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50764451 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50764448 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to Osseo integrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748969 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748967 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748943 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748938 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748918 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748915 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748914 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748913 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748912 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748911 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742863 ↗InjurySep 11, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742860 ↗InjurySep 11, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742859 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742858 ↗InjurySep 11, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742825 ↗InjurySep 11, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742824 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700736 ↗
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 · each recall links to the FDA recall notice
- 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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