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NobelReplace® 32220Recalls & reported problems

Nobel Biocare AB · NobelReplace® Tapered Groovy WP 5.0x10mm · Class 2 · Implant

Quick summary

This NobelReplace Tapered Groovy implant is a root-form device placed in bone. Its 3,036 adverse event reports mostly describe implants that lose or fail to fuse with the bone, and some mention fractures, infection and pain. The reports include no deaths and 3,033 injuries. 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
3,046
Deaths reported
0
Injuries reported
3,043
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3,046 adverse event reports that list this exact device (DI 07332747001884), received between Sep 11, 2019 and Sep 30, 2026 — classified as 3,043 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (2,273 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: 46 reportsDec 2023: 42 reportsJan 2024: 64 reportsFeb 2024: 10 reportsMar 2024: 33 reportsApr 2024: 40 reportsMay 2024: 38 reportsJun 2024: 30 reportsJul 2024: 22 reportsAug 2024: 26 reportsSep 2024: 42 reportsOct 2024: 48 reportsNov 2024: 40 reportsDec 2024: 27 reportsJan 2025: 29 reportsFeb 2025: 38 reportsMar 2025: 30 reportsApr 2025: 14 reportsMay 2025: 0 reportsJun 2025: 3 reportsJul 2025: 99 reportsAug 2025: 38 reportsSep 2025: 12 reportsOct 2025: 20 reportsNov 2025: 48 reportsDec 2025: 34 reportsJan 2026: 32 reportsFeb 2026: 44 reportsMar 2026: 27 reportsApr 2026: 40 reportsMay 2026: 36 reportsJun 2026: 27 reportsJul 2026: 39 reportsAug 2026: 27 reportsSep 2026: 10 reportsOct 2026: 0 reports20242025202699
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration2,273
  • Failure to Osseointegrate616
  • Osseointegration Problem79
  • Adverse Event Without Identified Device or Use Problem25
  • Fracture23
  • Insufficient Device Problem Information12
  • Migration10
  • Separation Failure4

Patient problems

  • Failure of Implant2,488
  • Unspecified Infection518
  • Pain400
  • No Clinical Signs, Symptoms or Conditions315
  • Numbness48
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available44
  • Abscess33
  • Inflammation14

Recent adverse event reports

The 25 most recent of 3,046 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Loss of Osseointegration

    Patient problems: Unspecified Infection

    MAUDE report 50954287 ↗
  • InjurySep 30, 2026Loss of Osseointegration

    Patient problems: Unspecified Infection

    MAUDE report 50954286 ↗
  • InjurySep 14, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764752 ↗
  • InjurySep 14, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764748 ↗
  • InjurySep 14, 2026Fracture

    Component fractured.

    Patient problems: Abscess

    MAUDE report 50749092 ↗
  • InjurySep 14, 2026Fracture

    Component fractured.

    Patient problems: Abscess

    MAUDE report 50749090 ↗
  • InjurySep 10, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50724282 ↗
  • InjurySep 10, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50724278 ↗
  • InjurySep 8, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50678694 ↗
  • InjurySep 8, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50678690 ↗
  • InjuryAug 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487027 ↗
  • InjuryAug 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487026 ↗
  • InjuryAug 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Osteomyelitis

    MAUDE report 50486813 ↗
  • InjuryAug 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Osteomyelitis

    MAUDE report 50486812 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332983 ↗
  • InjuryAug 16, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50266132 ↗
  • InjuryAug 16, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50265058 ↗
  • InjuryAug 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50263173 ↗
  • InjuryAug 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50263171 ↗
  • InjuryAug 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50263143 ↗
  • InjuryAug 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50263142 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50243241 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50243238 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50242319 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50242302 ↗

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.