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NobelReplace® 32211Recalls & reported problems

Nobel Biocare AB · NobelReplace® Tapered Groovy NP 3.5x8mm · Class 2 · Implant

Quick summary

This Nobel Biocare NobelReplace dental implant appears in 866 adverse event reports, with 860 injuries and no deaths. Most describe the implant losing or failing to fuse with the surrounding bone, and some mention pain, numbness and infection. 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
868
Deaths reported
0
Injuries reported
862
Recalls naming it
0

Summary

The FDA's MAUDE database contains 868 adverse event reports that list this exact device (DI 07332747001792), received between Sep 11, 2019 and Sep 17, 2026 — classified as 862 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (547 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 12 reportsDec 2023: 4 reportsJan 2024: 10 reportsFeb 2024: 4 reportsMar 2024: 12 reportsApr 2024: 8 reportsMay 2024: 4 reportsJun 2024: 26 reportsJul 2024: 6 reportsAug 2024: 14 reportsSep 2024: 16 reportsOct 2024: 14 reportsNov 2024: 16 reportsDec 2024: 0 reportsJan 2025: 8 reportsFeb 2025: 14 reportsMar 2025: 14 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 22 reportsAug 2025: 6 reportsSep 2025: 16 reportsOct 2025: 2 reportsNov 2025: 12 reportsDec 2025: 4 reportsJan 2026: 12 reportsFeb 2026: 10 reportsMar 2026: 6 reportsApr 2026: 14 reportsMay 2026: 2 reportsJun 2026: 2 reportsJul 2026: 4 reportsAug 2026: 2 reportsSep 2026: 2 reportsOct 2026: 0 reports20242025202626
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration547
  • Failure to Osseointegrate259
  • Fracture18
  • Osseointegration Problem17
  • Adverse Event Without Identified Device or Use Problem16
  • Material Deformation4
  • Insufficient Device Problem Information3
  • Malposition of Device2

Patient problems

  • Failure of Implant745
  • Pain126
  • Unspecified Infection89
  • No Clinical Signs, Symptoms or Conditions76
  • Numbness54
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
  • Abscess5
  • Inflammation4

Recent adverse event reports

The 25 most recent of 868 reports, in the reporter's own words as published by the FDA.

  • InjurySep 17, 2026Fracture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811172 ↗
  • InjurySep 17, 2026Fracture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811170 ↗
  • InjuryAug 12, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50228964 ↗
  • InjuryAug 12, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50228962 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50029940 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50029939 ↗
  • InjuryJul 3, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25707968 ↗
  • InjuryJul 3, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25707965 ↗
  • InjuryJun 25, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25629450 ↗
  • InjuryJun 25, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25629448 ↗
  • InjuryMay 5, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25087429 ↗
  • InjuryMay 5, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25087167 ↗
  • InjuryApr 30, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25051852 ↗
  • InjuryApr 30, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25051846 ↗
  • InjuryApr 29, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25037150 ↗
  • InjuryApr 29, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25037113 ↗
  • InjuryApr 28, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25023295 ↗
  • InjuryApr 28, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25023230 ↗
  • InjuryApr 21, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24946034 ↗
  • InjuryApr 21, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24946033 ↗
  • InjuryApr 15, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24890951 ↗
  • InjuryApr 15, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24890949 ↗
  • InjuryApr 9, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 24837395 ↗
  • InjuryApr 9, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 24837329 ↗
  • InjuryApr 9, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 24837285 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.