Replace Select™ 36288 (UDI 07332747022735)Recalls & reported problems

Nobel Biocare AB · Replace Select™ TC NP 3.5x(15+3)mm · Class 2 · Implant

Quick summary

This Nobel Biocare Replace Select dental implant is a root-form implant placed in the jaw to hold dental replacements. Reports mostly describe implants loosening or failing to bond with bone and parts breaking, often with pain. There are 24 reports naming its identifier, mentioning 24 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: 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 07332747022735), received between Sep 11, 2019 and Mar 21, 2024 — classified as 24 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (12 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 Osseointegration12
Failure to Osseointegrate6
Fracture6

Patient problems

Failure of Implant24
Pain7
Inflammation2
Unspecified Infection2

Recent adverse event reports

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

InjuryMar 21, 2024Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 18954269 ↗
InjuryMar 21, 2024Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 18954265 ↗
InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18890017 ↗
InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18890002 ↗
InjuryMay 26, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 17014107 ↗
InjuryMay 26, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 17013847 ↗
InjuryFeb 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16420459 ↗
InjuryFeb 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16420430 ↗
InjuryMar 11, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 13740571 ↗
InjuryMar 11, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 13740533 ↗
InjuryJan 14, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13261153 ↗
InjuryJan 14, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13261034 ↗
InjuryDec 16, 2021Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN /FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 13021071 ↗
InjuryDec 16, 2021Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN /FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 13021070 ↗
InjuryNov 27, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9381787 ↗
InjuryNov 5, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 9277764 ↗
InjuryNov 5, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 9277747 ↗
InjuryOct 9, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9170913 ↗
InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9061888 ↗
InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9061877 ↗
InjurySep 14, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9051930 ↗
InjurySep 14, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9051927 ↗
InjurySep 13, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9020801 ↗
InjurySep 11, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 8998877 ↗

Device details

UDI-DI	`07332747022735`
Brand	Replace Select™
Model	36288
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.