Replace® Select 28959Recalls & reported problems
Nobel Biocare AB · Replace Select Straight TiU WP 5.0x15mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is placed in the jaw to replace a tooth root. The 32 reports mostly describe the implant losing its attachment to the bone, along with infections, implant failure, and pain; they include no deaths and 32 injuries. No recalls name this device. Reports fell from 16 in the previous 12 months to 8 in the latest 12 months.
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
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07332747022612), received between Jun 16, 2022 and Dec 16, 2025 — classified as 32 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (30 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 Osseointegration30
- Osseointegration Problem2
Patient problems
- Unspecified Infection18
- Failure of Implant16
- Pain2
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 16, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17383701 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.