Nobel Biocare N1™ 300863Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC RP 4.0x13mm · 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 implant appears in 629 adverse event reports, including 623 injuries and no deaths. Most reports describe the implant not bonding with the bone, and some mention infection, pain, or shifting. There is 1 open recall, started in January 2025, over a pin from the molding process that may puncture packaging and break the sterile seal.
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
- 641
- Deaths reported
- 0
- Injuries reported
- 635
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 641 adverse event reports that list this exact device (DI 07332747161755), received between Feb 1, 2022 and Sep 30, 2026 — classified as 635 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (470 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 Osseointegrate470
- Loss of Osseointegration85
- Osseointegration Problem38
- Migration16
- Adverse Event Without Identified Device or Use Problem14
- Patient Device Interaction Problem6
- Premature Separation4
- Activation, Positioning or Separation Problem2
Patient problems
- Failure of Implant424
- No Clinical Signs, Symptoms or Conditions150
- Pain52
- Unspecified Infection43
- Implant Pain14
- Fistula10
- Foreign Body In Patient8
- Inflammation8
Recent adverse event reports
The 25 most recent of 641 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 50954307 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954305 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954301 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954300 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940500 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940493 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830880 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830878 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780533 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780532 ↗InjurySep 14, 2026Failure to Osseointegrate
InjurySep 14, 2026Failure to Osseointegrate
InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487008 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487007 ↗InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863418 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863406 ↗InjuryJul 15, 2026Loss of Osseointegration
InjuryJul 15, 2026Loss of Osseointegration
InjuryJul 15, 2026Loss of Osseointegration
InjuryJul 15, 2026Loss of Osseointegration
InjuryJul 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740218 ↗InjuryJul 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740197 ↗InjuryJul 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740188 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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