Nobel Biocare N1™ 300861Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC RP 4.0x9mm · 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 root-form implant is placed in bone. Most of the 1,365 reports describe the implant failing to bond with the bone or losing that bond, and some mention pain or infection. The reports include no deaths and 1,359 injuries. One recall names this device and is open, covering a manufacturing problem in which a sharp pin could puncture blister packaging and compromise the sterile barrier, starting January 2025.
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
- 1,393
- Deaths reported
- 0
- Injuries reported
- 1,387
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,393 adverse event reports that list this exact device (DI 07332747161731), received between Jan 27, 2022 and Sep 19, 2026 — classified as 1,387 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (949 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 Osseointegrate949
- Loss of Osseointegration250
- Osseointegration Problem104
- Adverse Event Without Identified Device or Use Problem26
- Material Deformation18
- Patient Device Interaction Problem18
- Defective Device10
- Malposition of Device10
Patient problems
- Failure of Implant892
- No Clinical Signs, Symptoms or Conditions364
- Pain92
- Unspecified Infection80
- Implant Pain28
- Inflammation28
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available23
- Fistula22
Recent adverse event reports
The 25 most recent of 1,393 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833496 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833495 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Implant Pain
MAUDE report 50830461 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Implant Pain
MAUDE report 50830460 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795740 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795732 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50780917 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50780916 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780802 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780788 ↗InjurySep 15, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780526 ↗InjurySep 15, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780524 ↗InjurySep 14, 2026Failure to Osseointegrate
InjurySep 14, 2026Failure to Osseointegrate
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743964 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743962 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701224 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701223 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701159 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701158 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50700747 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50700744 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700245 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700242 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678323 ↗
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- 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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