Replace Select™ 36105 (UDI 07332747022636)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU NP 3.5x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant has 393 reports in the FDA database, 389 of them describing injuries and no deaths. Most reports describe the bone failing to grow onto the implant or losing its hold on it, after which the implant fails. Some also mention pain and infection. 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
- 393
- Deaths reported
- 0
- Injuries reported
- 389
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 393 adverse event reports that list this exact device (DI 07332747022636), received between Sep 11, 2019 and Mar 19, 2026 — classified as 389 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (184 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 Osseointegrate184
- Loss of Osseointegration180
- Fracture14
- Osseointegration Problem10
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Failure of Implant367
- Pain56
- Unspecified Infection42
- Numbness9
- Abscess4
- No Clinical Signs, Symptoms or Conditions4
- Osteomyelitis2
Recent adverse event reports
The 25 most recent of 393 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2026Loss of Osseointegration
InjuryMar 19, 2026Loss of Osseointegration
InjuryFeb 4, 2026Loss of Osseointegration
InjuryFeb 4, 2026Loss of Osseointegration
InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24170926 ↗InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24170922 ↗InjuryJan 23, 2026Loss of Osseointegration
InjuryJan 23, 2026Loss of Osseointegration
InjuryDec 12, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 12, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 18, 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 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453705 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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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.