NobelReplace® 36901Recalls & reported problems

Nobel Biocare AB · NobelReplace PS WP 6.0x8mm · Class 2 · Implant

Quick summary

This is a Nobel Biocare NobelReplace dental implant. There are 24 reports naming its identifier, all involving injuries and no deaths; they mostly describe the implant failing to fuse with the jawbone, sometimes with infection, abscess or pain, and a few mention the implant fracturing. 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: 24
Deaths reported: 0
Injuries reported: 24
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07332747034042), received between Feb 9, 2022 and Jan 13, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (22 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

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

Most reported problems

Device problems

Loss of Osseointegration22
Fracture2

Patient problems

Failure of Implant18
Unspecified Infection6
Abscess4
Pain4
No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061984 ↗
InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061981 ↗
InjuryAug 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22695310 ↗
InjuryAug 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22695306 ↗
InjuryAug 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22695300 ↗
InjuryAug 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22695299 ↗
InjuryJun 10, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19504556 ↗
InjuryJun 10, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19504555 ↗
InjuryFeb 14, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18707122 ↗
InjuryFeb 14, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18707100 ↗
InjuryDec 15, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18339898 ↗
InjuryDec 15, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18339897 ↗
InjuryMay 10, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16906285 ↗
InjuryMay 10, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16906238 ↗
InjuryApr 7, 2023Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED.
Patient problems: Failure of Implant
MAUDE report 16703278 ↗
InjuryApr 7, 2023Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED.
Patient problems: Failure of Implant
MAUDE report 16703261 ↗
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 16299263 ↗
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 16299240 ↗
InjuryJul 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 14949637 ↗
InjuryJul 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 14949492 ↗
InjuryMar 29, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13942525 ↗
InjuryMar 29, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13942469 ↗
InjuryFeb 9, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13501453 ↗
InjuryFeb 9, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13501438 ↗

Device details

UDI-DI	`07332747034042`
Brand	NobelReplace®
Model	36901
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	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Sep 28, 2020

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.