NobelReplace® 32218Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy RP 4.3x16mm · Class 2 · Implant
All models of NobelReplace (120)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant has 426 reports, all listed as injuries, and no deaths. Most reports describe the implant losing its bond with the jawbone, and some mention numbness, pain or infection. Reports rose to 65 in the last year from 35 in the year before. 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
- 426
- Deaths reported
- 0
- Injuries reported
- 426
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 426 adverse event reports that list this exact device (DI 07332747001860), received between Sep 11, 2019 and Aug 14, 2026 — classified as 426 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (363 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration363
- Failure to Osseointegrate31
- Osseointegration Problem12
- Adverse Event Without Identified Device or Use Problem8
- Fracture4
- Insufficient Device Problem Information4
- Migration4
- Difficult to Remove2
Patient problems
- Failure of Implant333
- Unspecified Infection52
- No Clinical Signs, Symptoms or Conditions46
- Pain42
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Numbness10
- Abscess4
- Foreign Body In Patient4
Recent adverse event reports
The 25 most recent of 426 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262692 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262691 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243060 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243059 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243051 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243048 ↗InjuryAug 6, 2026Loss of Osseointegration
InjuryAug 6, 2026Loss of Osseointegration
InjuryAug 6, 2026Loss of Osseointegration
InjuryAug 6, 2026Loss of Osseointegration
InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107036 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107035 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107034 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107031 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601161 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601158 ↗InjuryJun 3, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25266130 ↗InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25266127 ↗InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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