NobelActive® TiUltra™ 300258Recalls & reported problems

Nobel Biocare AB · NobelActive® TiUltra™ RP 5.0x11.5mm · Class 2 · Implant

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

Quick summary

This NobelActive TiUltra dental implant is made by Nobel Biocare. Of its 2,453 reports, 2,407 are injury reports and 46 are malfunction reports, and most describe the implant failing to bond with the bone. Some describe the implant shifting, and reports also mention infection and pain. There are no deaths, and 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: 2,503
Deaths reported: 0
Injuries reported: 2,457
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2,503 adverse event reports that list this exact device (DI 07332747127492), received between Oct 29, 2021 and Sep 30, 2026 — classified as 2,457 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1,777 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 Osseointegrate1,777
Loss of Osseointegration261
Osseointegration Problem223
Patient Device Interaction Problem70
Adverse Event Without Identified Device or Use Problem56
Migration22
Fracture20
Difficult to Insert18

Patient problems

Failure of Implant1,581
No Clinical Signs, Symptoms or Conditions689
Unspecified Infection211
Pain136
Numbness28
Abscess24
Implant Pain24
Inflammation22

Recent adverse event reports

The 25 most recent of 2,503 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953534 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953533 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940533 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940531 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940285 ↗
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940283 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50833608 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50833606 ↗
InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833582 ↗
InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833579 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830083 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830081 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830078 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830077 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810553 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810551 ↗
InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796306 ↗
InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796296 ↗
InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796072 ↗
InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796071 ↗
InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780739 ↗
InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780737 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743019 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743013 ↗
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724378 ↗

Device details

UDI-DI	`07332747127492`
Brand	NobelActive® TiUltra™
Model	300258
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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