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Replace Select™ 29423 (UDI 07332747000160)Recalls & reported problems

Nobel Biocare AB · Replace Select™ Tapered TiU WP 5.0x10mm · Class 2 · Implant

Quick summary

This Nobel Biocare Replace Select dental implant appears in 892 adverse event reports, with 891 injuries and no deaths. Most describe the implant failing to fuse with the surrounding bone, and some mention pain, numbness or 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
892
Deaths reported
0
Injuries reported
891
Recalls naming it
0

Summary

The FDA's MAUDE database contains 892 adverse event reports that list this exact device (DI 07332747000160), received between Sep 11, 2019 and May 26, 2026 — classified as 891 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (640 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: 18 reportsJan 2024: 14 reportsFeb 2024: 3 reportsMar 2024: 15 reportsApr 2024: 8 reportsMay 2024: 45 reportsJun 2024: 17 reportsJul 2024: 0 reportsAug 2024: 4 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 12 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 4 reportsSep 2025: 0 reportsOct 2025: 4 reportsNov 2025: 4 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 4 reportsMar 2026: 14 reportsApr 2026: 6 reportsMay 2026: 4 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202645
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration640
  • Failure to Osseointegrate218
  • Osseointegration Problem18
  • Adverse Event Without Identified Device or Use Problem9
  • Fracture4
  • Insufficient Device Problem Information3
  • Mechanical Problem1
  • Missing Information1

Patient problems

  • Failure of Implant844
  • Pain145
  • Unspecified Infection101
  • Numbness39
  • No Clinical Signs, Symptoms or Conditions29
  • Abscess4
  • Bone Fracture(s)3
  • Inflammation3

Recent adverse event reports

The 25 most recent of 892 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 26, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25288886 ↗
  • InjuryMay 26, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25288850 ↗
  • InjuryMay 1, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25061867 ↗
  • InjuryMay 1, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25061864 ↗
  • InjuryApr 25, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24992822 ↗
  • InjuryApr 25, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24992821 ↗
  • InjuryApr 2, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24771088 ↗
  • InjuryApr 2, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24771086 ↗
  • InjuryApr 1, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24759348 ↗
  • InjuryApr 1, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24759345 ↗
  • InjuryMar 6, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 24538018 ↗
  • InjuryMar 6, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 24537851 ↗
  • InjuryMar 5, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24525652 ↗
  • InjuryMar 5, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24525651 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479255 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE. THE PRODUCT HAS BEEN RETURNED AND THE MATERIAL NUMBER UPDATED ACCORDINGLY. THE CORRECTED INFORMATION IS PROVIDED IN THIS FOLLOW UP REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479247 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479191 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479190 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479184 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE. THE PRODUCT HAS BEEN RETURNED AND THE MATERIAL NUMBER UPDATED ACCORDINGLY. THE CORRECTED INFORMATION IS PROVIDED IN THIS FOLLOW UP REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479183 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479125 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479053 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479034 ↗
  • InjuryMar 2, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24479028 ↗
  • InjuryFeb 17, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24370972 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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