Replace® Select 28946Recalls & reported problems
Nobel Biocare AB · Replace Select Straight TiU NP 3.5x10mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Replace Select dental implant is a screw-shaped titanium post used as a root for a replacement tooth. Most of the 62 reports describe the implant failing to bond with the surrounding bone, along with a few cases of the post breaking or shifting, and symptoms such as pain, infection, inflammation, or numbness. No deaths were reported; all 62 reports involve 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
- 62
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 07332747022490), received between Nov 16, 2021 and Jun 30, 2026 — classified as 62 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (46 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 Osseointegration46
- Failure to Osseointegrate6
- Fracture4
- Osseointegration Problem4
- Migration2
Patient problems
- Failure of Implant46
- Unspecified Infection10
- Pain6
- Inflammation4
- No Clinical Signs, Symptoms or Conditions4
- Abscess2
- Foreign Body In Patient2
- Numbness2
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
InjuryMar 25, 2026Loss of Osseointegration
InjuryMar 25, 2026Loss of Osseointegration
InjuryDec 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23890578 ↗InjuryDec 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23890576 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22989489 ↗InjurySep 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22989478 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21648078 ↗InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21648069 ↗InjuryJan 29, 2025Fracture; Fracture
InjuryJan 29, 2025Fracture; Fracture
InjuryOct 31, 2024Fracture; Fracture
InjuryOct 31, 2024Fracture; Fracture
InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMar 12, 2024Migration; Migration
IMPLANT FAILED DUE TO PART MIGRATES.
Patient problems: Foreign Body In Patient
MAUDE report 18889468 ↗InjuryMar 12, 2024Migration; Migration
IMPLANT FAILED DUE TO PART MIGRATES.
Patient problems: Foreign Body In Patient
MAUDE report 18889463 ↗InjuryOct 26, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18014771 ↗
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- 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
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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