Nobel Biocare N1Recalls & reported problems across all models
Nobel Biocare AB · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Nobel Biocare N1 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6,666
- Deaths reported
- 0
- Injuries reported
- 6,610
- Recalls
- 2
We found 13 models of Nobel Biocare N1 by Nobel Biocare AB in the FDA's device registry (GUDID). Together they are named in 6,666 adverse event reports in the FDA's MAUDE database, received between Jan 27, 2022 and Sep 30, 2026 — classified as 6,610 injuries, 56 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4,613 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. 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
Nobel Biocare N1 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
- Jul 25, 2022Class IIOpen, Classified
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Z-1565-2022 · Root cause: Process change control · Recall details · FDA record ↗
Most reported Nobel Biocare N1 problems
Device problems
- Failure to Osseointegrate4,613
- Loss of Osseointegration1,109
- Osseointegration Problem495
- Adverse Event Without Identified Device or Use Problem140
- Migration78
- Patient Device Interaction Problem68
- Material Deformation34
- Premature Separation34
Patient problems
- Failure of Implant4,070
- No Clinical Signs, Symptoms or Conditions1,924
- Unspecified Infection448
- Pain378
- Implant Pain164
- Inflammation128
- Abscess79
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available75
Nobel Biocare N1 models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Nobel Biocare N1™ 300861IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall1,393 reports
- Nobel Biocare N1™ 300862IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall1,280 reports
- Nobel Biocare N1™ 300858IMPLANT, ENDOSSEOUS, ROOT-FORM708 reports
- Nobel Biocare N1™ 300863IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall641 reports
- Nobel Biocare N1™ 300857IMPLANT, ENDOSSEOUS, ROOT-FORM641 reports
- Nobel Biocare N1™ 300860IMPLANT, ENDOSSEOUS, ROOT-FORM558 reports
- Nobel Biocare N1™ 300859IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall464 reports
- Nobel Biocare N1™ 300865IMPLANT, ENDOSSEOUS, ROOT-FORM317 reports
- Nobel Biocare N1™ 300866IMPLANT, ENDOSSEOUS, ROOT-FORM192 reports
- Nobel Biocare N1™ 301170IMPLANT, ENDOSSEOUS, ROOT-FORM183 reports
- Nobel Biocare N1™ 300864IMPLANT, ENDOSSEOUS, ROOT-FORM176 reports
- Nobel Biocare N1™ 301169IMPLANT, ENDOSSEOUS, ROOT-FORM111 reports
- Nobel Biocare N1™ 301048Abutment, implant, dental, endosseous2 reports
Recent Nobel Biocare N1 adverse event reports
The 15 most recent reports across all models, 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 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 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954284 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954273 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954047 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954040 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50953410 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50953408 ↗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 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940482 ↗
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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