Replace Select™ 37309 (UDI 07332747073409)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC RP 4.3x16mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is a tapered screw-shaped implant used as a tooth root replacement. The 54 reports mostly describe the implant not fusing properly with the jawbone or later losing that fusion, so the implant fails and has to be removed; a few mention the implant fracturing, plus pain, numbness, and infection. All54 reports describe injuries, with no deaths. There are no recalls naming 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
- 54
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07332747073409), received between Sep 11, 2019 and Jul 27, 2026 — classified as 54 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (23 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 Osseointegration23
- Failure to Osseointegrate17
- Osseointegration Problem10
- Fracture4
Patient problems
- Failure of Implant52
- Pain6
- No Clinical Signs, Symptoms or Conditions2
- Numbness2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046644 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046643 ↗InjuryJan 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 18429805 ↗InjuryJan 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 18429790 ↗InjuryDec 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18368192 ↗InjuryDec 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18368176 ↗InjuryDec 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18313875 ↗InjuryDec 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18313833 ↗InjuryOct 30, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18033406 ↗InjuryOct 30, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18033402 ↗InjuryAug 8, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17483430 ↗InjuryAug 8, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17483162 ↗InjuryApr 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16819118 ↗InjuryApr 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16819117 ↗InjuryMar 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16532072 ↗InjuryMar 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16532041 ↗InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 16298523 ↗InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 16298467 ↗InjuryOct 21, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15655502 ↗InjuryOct 21, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15654738 ↗InjuryOct 21, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15653905 ↗InjuryOct 21, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15653770 ↗InjuryAug 25, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 15296960 ↗InjuryAug 25, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 15296906 ↗InjuryAug 16, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 15235894 ↗
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.