NobelReplace® 32217Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy RP 4.3x13mm · Class 2 · Implant
Quick summary
This NobelReplace Tapered Groovy implant is a root-form device placed in bone. Its 3,064 adverse event reports mostly describe implants that fail to fuse with the surrounding bone or lose that connection, and some mention fractures, migration, infection and pain. The reports include no deaths and 3,048 injuries. 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
- 3,082
- Deaths reported
- 0
- Injuries reported
- 3,066
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,082 adverse event reports that list this exact device (DI 07332747001853), received between Jul 31, 2018 and Sep 30, 2026 — classified as 3,066 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (2,404 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 Osseointegration2,404
- Failure to Osseointegrate416
- Osseointegration Problem127
- Fracture64
- Adverse Event Without Identified Device or Use Problem44
- Migration14
- Insufficient Device Problem Information6
- Separation Failure5
Patient problems
- Failure of Implant2,484
- Unspecified Infection532
- Pain481
- No Clinical Signs, Symptoms or Conditions282
- Numbness139
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available57
- Abscess26
- Implant Pain18
Recent adverse event reports
The 25 most recent of 3,082 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50954281 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50954277 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796134 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796132 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749165 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749162 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743081 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743079 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724209 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724206 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700679 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700678 ↗InjuryAug 26, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50463483 ↗InjuryAug 26, 2026Loss of Osseointegration
InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358630 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332443 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332441 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332437 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332436 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215567 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215566 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215550 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215541 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215540 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215534 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.