Replace Select™ 29401 (UDI 07332747000108)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU NP 3.5x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is placed in the jawbone. Its 828 reports include 820 injuries and no deaths. Most describe the implant failing to bond with the bone or losing that bond over time, with pain and infection in some patients. 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
- 832
- Deaths reported
- 0
- Injuries reported
- 824
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 832 adverse event reports that list this exact device (DI 07332747000108), received between Oct 31, 2018 and Sep 17, 2026 — classified as 824 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (460 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
Most reported problems
Device problems
- Loss of Osseointegration460
- Failure to Osseointegrate312
- Fracture25
- Osseointegration Problem20
- Adverse Event Without Identified Device or Use Problem13
- Material Deformation4
- Insufficient Device Problem Information2
- Device Damaged by Another Device1
Patient problems
- Failure of Implant774
- Pain154
- Unspecified Infection88
- Numbness50
- No Clinical Signs, Symptoms or Conditions38
- Abscess7
- Implant Pain2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 832 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811945 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811943 ↗InjuryAug 22, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50392917 ↗InjuryAug 22, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50392905 ↗InjuryAug 18, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310169 ↗InjuryAug 18, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310166 ↗InjuryMar 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24657525 ↗InjuryMar 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24657524 ↗InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24360512 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24360510 ↗InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24356366 ↗InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24356364 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24352316 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24352312 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24138935 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24138931 ↗InjuryJan 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032359 ↗InjuryJan 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032311 ↗InjuryDec 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.