Replace Select™ 36292 (UDI 07332747022766)Recalls & reported problems

Nobel Biocare AB · Replace Select™ TC RP 4.0x(15+3)mm · Class 2 · Implant

Quick summary

This Nobel Biocare Replace Select dental implant is placed in the jaw to support replacement teeth. Reports mostly describe implants loosening because they did not stay bonded to the bone, with some breaking, and mention implant failure and pain. There are 24 reports, with 24 injuries and no deaths,

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 07332747022766), received between Sep 11, 2019 and Oct 6, 2023 — classified as 24 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (15 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 Osseointegration15
Fracture8
Failure to Osseointegrate1

Patient problems

Failure of Implant24
Pain9
Unspecified Infection2

Recent adverse event reports

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

InjuryOct 6, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17889838 ↗
InjuryOct 6, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17889683 ↗
InjurySep 1, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17673647 ↗
InjurySep 1, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17673269 ↗
InjuryAug 25, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17628178 ↗
InjuryAug 25, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17626634 ↗
InjuryFeb 8, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 16328368 ↗
InjuryFeb 8, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 16328359 ↗
InjuryNov 11, 2022Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 15782797 ↗
InjuryNov 11, 2022Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 15782715 ↗
InjuryJun 13, 2022Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 14679598 ↗
InjuryJun 13, 2022Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 14679576 ↗
InjuryJun 10, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 14658290 ↗
InjuryJun 10, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 14658280 ↗
InjuryMar 11, 2022Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN /FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 13740560 ↗
InjuryMar 11, 2022Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN /FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 13740531 ↗
InjuryDec 29, 2021Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 13113234 ↗
InjuryDec 29, 2021Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/ FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 13113220 ↗
InjuryNov 5, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9277541 ↗
InjuryOct 9, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 9170879 ↗
InjurySep 13, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 9020742 ↗
InjurySep 13, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 9020719 ↗
InjurySep 11, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 8998794 ↗
InjurySep 11, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 8998792 ↗

Device details

UDI-DI	`07332747022766`
Brand	Replace Select™
Model	36292
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	Oct 12, 2023

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