Replace Select™ 36292 (UDI 07332747160444)Recalls & reported problems
Nobel Biocare AB · Replace Select™ TC RP 4.0x(15+3)mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Replace Select dental implant is placed in the jawbone. Reports describe implants that failed to fuse with the bone or later lost that fusion, components fracturing, and patients with pain, infection or numbness. There are 111 reports, all of them 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
- 111
- Deaths reported
- 0
- Injuries reported
- 111
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 07332747160444), received between Dec 10, 2021 and Mar 31, 2026 — classified as 111 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (62 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 Osseointegrate62
- Loss of Osseointegration23
- Fracture12
- Insufficient Device Problem Information8
- Osseointegration Problem6
Patient problems
- Failure of Implant91
- Pain50
- Unspecified Infection24
- Numbness14
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748368 ↗InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748345 ↗InjuryMar 26, 2026Loss of Osseointegration
InjuryMar 26, 2026Loss of Osseointegration
InjuryNov 4, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470765 ↗InjuryNov 4, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470638 ↗InjuryNov 4, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470637 ↗InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 4, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470455 ↗InjuryNov 4, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470318 ↗InjuryNov 4, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470316 ↗InjuryMar 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21589636 ↗InjuryMar 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21589633 ↗InjuryMar 12, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 12, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 12, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 4, 2024Fracture; Fracture
InjuryDec 4, 2024Fracture; Fracture
InjuryDec 4, 2024Fracture; Fracture
InjuryDec 4, 2024Fracture; Fracture
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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