NobelActive® TiUltra™ 300252Recalls & reported problems

Nobel Biocare AB · NobelActive® TiUltra™ RP 4.3x11.5mm · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare NobelActive implant is placed in bone. Reports mostly describe the implant failing to bond with the surrounding bone, along with pain, infection, and abscesses. There are 7,519 reports, including 1 death and 7,397 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: 7,572
Deaths reported: 1
Injuries reported: 7,450
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7,572 adverse event reports that list this exact device (DI 07332747127430), received between Oct 29, 2021 and Sep 30, 2026 — classified as 1 death, 7,450 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5,126 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate5,126
Loss of Osseointegration1,019
Osseointegration Problem693
Adverse Event Without Identified Device or Use Problem238
Patient Device Interaction Problem156
Fracture100
Migration73
Difficult to Insert38

Patient problems

Failure of Implant4,914
No Clinical Signs, Symptoms or Conditions1,978
Pain574
Unspecified Infection507
Abscess146
Inflammation137
Implant Pain88
Numbness85

Recent adverse event reports

The 25 most recent of 7,572 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953118 ↗
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953117 ↗
InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940794 ↗
InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940793 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940574 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940573 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940248 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940247 ↗
InjurySep 27, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910433 ↗
InjurySep 27, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910426 ↗
InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833597 ↗
InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833595 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833549 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833535 ↗
InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833371 ↗
InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833367 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50833295 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50833293 ↗
InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832828 ↗
InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832827 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830626 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830625 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830549 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830541 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830432 ↗

Device details

UDI-DI	`07332747127430`
Brand	NobelActive® TiUltra™
Model	300252
Company	Nobel Biocare AB
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 7, 2025

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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