NobelReplace® 32215Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy RP 4.3x8mm · Class 2 · Implant
Quick summary
This NobelReplace dental implant is a root-form implant placed in the jaw to support a replacement tooth. Its 1,601 reports mostly describe the implant losing or failing to bond with the jawbone, and some mention pain or infection. The reports include 1,597 injuries and no deaths. 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
- 1,615
- Deaths reported
- 0
- Injuries reported
- 1,611
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,615 adverse event reports that list this exact device (DI 07332747001839), received between Sep 11, 2019 and Sep 18, 2026 — classified as 1,611 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (1,268 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 Osseointegration1,268
- Failure to Osseointegrate278
- Osseointegration Problem44
- Fracture14
- Adverse Event Without Identified Device or Use Problem6
- Insufficient Device Problem Information2
- Patient Device Interaction Problem2
- Material Deformation1
Patient problems
- Failure of Implant1,265
- Pain237
- No Clinical Signs, Symptoms or Conditions194
- Unspecified Infection191
- Numbness56
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available43
- Implant Pain13
- Inflammation10
Recent adverse event reports
The 25 most recent of 1,615 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50830050 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50830048 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812083 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812080 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796391 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796389 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764817 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764815 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764807 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764804 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764798 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764789 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50701258 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50701256 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50331837 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50331826 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50267478 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50265624 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167014 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167013 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013558 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013557 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50002640 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.