NobelReplace® 32181Recalls & reported problems
Nobel Biocare AB · NOBELREPLACE® Straight Groovy RP 4x10mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This NobelReplace implant has 229 adverse event reports, all of them injuries, and no deaths. The reports mostly describe the implant losing its bond with the bone, with some describing infection and pain. 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
- 232
- Deaths reported
- 0
- Injuries reported
- 232
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 07332747019094), received between Sep 11, 2019 and Sep 11, 2026 — classified as 232 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (192 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 Osseointegration192
- Osseointegration Problem12
- Failure to Osseointegrate8
- Fracture8
- Insufficient Device Problem Information4
- Adverse Event Without Identified Device or Use Problem2
- Material Deformation2
- Mechanical Problem2
Patient problems
- Failure of Implant185
- Unspecified Infection42
- Pain30
- No Clinical Signs, Symptoms or Conditions25
- Numbness6
- Insufficient Information4
- Abscess2
- Fistula2
Recent adverse event reports
The 25 most recent of 232 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743575 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743572 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358100 ↗InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061803 ↗InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061801 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027013 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027012 ↗InjuryJun 23, 2026Loss of Osseointegration
InjuryJun 23, 2026Loss of Osseointegration
InjuryJun 23, 2026Loss of Osseointegration
InjuryJun 23, 2026Loss of Osseointegration
InjuryJun 6, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420283 ↗InjuryJun 6, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420280 ↗InjuryApr 9, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836413 ↗InjuryApr 9, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836405 ↗InjuryMar 12, 2026Loss of Osseointegration
InjuryMar 12, 2026Loss of Osseointegration
InjuryFeb 26, 2026Loss of Osseointegration
InjuryFeb 26, 2026Loss of Osseointegration
InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845550 ↗InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845516 ↗InjuryNov 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624198 ↗InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622922 ↗
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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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