NobelReplace® 32223Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy 6.0 6.0x8mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace Tapered Groovy implant is a root-form implant placed into bone. All 163 of its adverse event reports are injuries, with no deaths. Most describe the implant losing its bond with the bone, and reports also mention infection, pain and 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
- 167
- Deaths reported
- 0
- Injuries reported
- 167
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 07332747001914), received between Sep 11, 2019 and Sep 18, 2026 — classified as 167 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (139 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 Osseointegration139
- Failure to Osseointegrate22
- Adverse Event Without Identified Device or Use Problem4
- Fracture2
- Osseointegration Problem1
Patient problems
- Failure of Implant142
- Unspecified Infection37
- Pain27
- No Clinical Signs, Symptoms or Conditions16
- Numbness10
- Inflammation4
- Fistula2
- Abscess1
Recent adverse event reports
The 25 most recent of 167 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830578 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830575 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50743249 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50743248 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385276 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385263 ↗InjuryMay 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25261776 ↗InjuryMay 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25261772 ↗InjuryApr 3, 2026Loss of Osseointegration
InjuryApr 3, 2026Loss of Osseointegration
InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24359005 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24359000 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675128 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675116 ↗InjuryJul 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22621700 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22614135 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22442433 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22442397 ↗InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22354222 ↗InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22354086 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.