Replace Select™ 36107 (UDI 07332747022674)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU RP 4.3x11.5mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Replace Select dental implant has 518 adverse event reports, with no deaths and 518 injuries. Most reports describe the implant losing its bond with bone or failing to fuse, and some mention infection, pain and numbness. No recalls name this device. Reports fell to 16 in the last 12 months from 28 in the year before.
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
- 518
- Deaths reported
- 0
- Injuries reported
- 518
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 518 adverse event reports that list this exact device (DI 07332747022674), received between Sep 11, 2019 and Jul 27, 2026 — classified as 518 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (264 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 Osseointegration264
- Failure to Osseointegrate213
- Osseointegration Problem23
- Fracture10
- Adverse Event Without Identified Device or Use Problem4
- Patient Device Interaction Problem2
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Failure of Implant480
- Unspecified Infection77
- Pain75
- Numbness16
- No Clinical Signs, Symptoms or Conditions12
- Abscess4
- Implant Pain2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 518 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
InjuryApr 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852830 ↗InjuryApr 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24841320 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryJan 23, 2026Loss of Osseointegration
InjuryJan 23, 2026Loss of Osseointegration
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833989 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833987 ↗InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470639 ↗InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23470248 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761429 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761400 ↗InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2025Loss 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.
How reports and recalls are matched · Editorial policy · Report an error on this page