Replace Select™ 36108 (UDI 07332747022704)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU WP 5.0x8mm · 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 post placed in the jawbone to hold a replacement tooth. Most of the 292 reports describe the implant failing to fuse with the bone or losing its bond with the bone, and some describe pain or infection. The number of reports fell from 24 in the prior 12 months to 6 in the last 12 months. The reports include no deaths and 292 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
- 294
- Deaths reported
- 0
- Injuries reported
- 294
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 07332747022704), received between Sep 11, 2019 and Sep 28, 2026 — classified as 294 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (154 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 Osseointegrate154
- Loss of Osseointegration130
- Osseointegration Problem6
- Adverse Event Without Identified Device or Use Problem3
- Fracture2
- Migration1
Patient problems
- Failure of Implant284
- Pain21
- Unspecified Infection15
- No Clinical Signs, Symptoms or Conditions8
- Numbness6
- Abscess1
- Inflammation1
Recent adverse event reports
The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924608 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924606 ↗InjuryApr 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24759375 ↗InjuryApr 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24759373 ↗InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24350634 ↗InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24350633 ↗InjuryNov 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453605 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453214 ↗InjuryJan 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 3, 2024Loss of Osseointegration; Loss of Osseointegration
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 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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