Replace® Select 28957Recalls & reported problems
Nobel Biocare AB · Replace Select Straight TiU WP 5.0x11.5 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Replace Select dental implant has 94 reports, all describing injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone, and some mention infection and pain. Reports fell from 14 in the prior 12 months to 6 in the latest 12 months. 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
- 96
- Deaths reported
- 0
- Injuries reported
- 96
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 07332747022599), received between Nov 15, 2021 and Sep 19, 2026 — classified as 96 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (68 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 Osseointegration68
- Failure to Osseointegrate20
- Osseointegration Problem4
- Fracture2
- Material Deformation2
Patient problems
- Failure of Implant80
- No Clinical Signs, Symptoms or Conditions8
- Pain8
- Unspecified Infection8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Inflammation2
- Numbness2
Recent adverse event reports
The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833545 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833544 ↗InjuryFeb 2, 2026Loss of Osseointegration
InjuryFeb 2, 2026Loss of Osseointegration
InjuryJan 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23953565 ↗InjuryJan 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23953559 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675244 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675240 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630582 ↗InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22623512 ↗InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22623454 ↗InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22623352 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22428843 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22428838 ↗InjuryMar 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20930433 ↗InjuryDec 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20930392 ↗InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 20574373 ↗InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 20574246 ↗InjuryJul 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19801759 ↗
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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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