NobelReplace® 32221Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy WP 5.0x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is the subject of 1,048 adverse event reports, which mention no deaths and 1,043 injuries. Most reports describe implants that lost or never gained their bond with the jawbone. Some also mention infection, pain, abscess or numbness. 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
- 1,048
- Deaths reported
- 0
- Injuries reported
- 1,043
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,048 adverse event reports that list this exact device (DI 07332747001891), received between Sep 11, 2019 and Aug 13, 2026 — classified as 1,043 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (809 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 Osseointegration809
- Failure to Osseointegrate175
- Osseointegration Problem24
- Adverse Event Without Identified Device or Use Problem18
- Fracture6
- Insufficient Device Problem Information5
- Migration5
- Difficult to Insert2
Patient problems
- Failure of Implant862
- Unspecified Infection193
- Pain132
- No Clinical Signs, Symptoms or Conditions91
- Abscess20
- Numbness18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Inflammation7
Recent adverse event reports
The 25 most recent of 1,048 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243231 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243225 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182970 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182969 ↗InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683852 ↗InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683851 ↗InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683198 ↗InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683192 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601504 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601503 ↗InjuryJun 17, 2026Loss of Osseointegration
InjuryJun 17, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479158 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479140 ↗InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss of Osseointegration
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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.