Replace Select™ 37317 (UDI 07332747160970)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC 6.0 6.0x11.5mm · Class 2 · Implant
Quick summary
This is a Nobel Biocare Replace Select dental implant, a screw-shaped root-form fixture used to anchor a tooth replacement. The 68 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that bond after it had formed, along with pain, inflammation, numbness and infection. All68 report injuries and no deaths. 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
- 68
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 07332747160970), received between May 23, 2022 and Aug 27, 2026 — classified as 68 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (50 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
- Failure to Osseointegrate50
- Loss of Osseointegration14
- Osseointegration Problem4
Patient problems
- Failure of Implant52
- No Clinical Signs, Symptoms or Conditions14
- Pain12
- Inflammation2
- Numbness2
- Unspecified Infection2
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487054 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487044 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229310 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229307 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229305 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229299 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229222 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229216 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229214 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229213 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229200 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229196 ↗InjuryApr 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25052138 ↗InjuryApr 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25052134 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 27, 2025Osseointegration Problem; Osseointegration Problem
InjuryMar 27, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 22, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 22, 2025Osseointegration Problem; Osseointegration Problem
InjuryJan 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19487520 ↗InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19482346 ↗InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18851290 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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
- 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.