Replace Select™ 37311 (UDI 07332747160918)Recalls & reported problems

Nobel Biocare AB · Replace Select™ Tapered PMC WP 5.0x10mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare Replace Select dental implant is placed in the jawbone. Its 826 reports include 815 injuries and no deaths. Most describe the implant failing to bond with the bone or losing that bond, and some describe pain and infection. Reports fell to 83 in the last 12 months, down from 171 in the 12 months before. 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: 841
Deaths reported: 0
Injuries reported: 830
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 841 adverse event reports that list this exact device (DI 07332747160918), received between Oct 29, 2021 and Sep 30, 2026 — classified as 830 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (507 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

Failure to Osseointegrate507
Loss of Osseointegration224
Osseointegration Problem50
Adverse Event Without Identified Device or Use Problem26
Patient Device Interaction Problem10
Difficult to Insert8
Migration6
Device Markings/Labelling Problem4

Patient problems

Failure of Implant637
No Clinical Signs, Symptoms or Conditions145
Pain109
Unspecified Infection98
Numbness16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available13
Abscess12
Implant Pain10

Recent adverse event reports

The 25 most recent of 841 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50954324 ↗
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50954316 ↗
InjurySep 19, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50833627 ↗
InjurySep 19, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50833624 ↗
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830298 ↗
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830292 ↗
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830270 ↗
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830268 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811097 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811094 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749261 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749259 ↗
InjurySep 14, 2026Migration
Device moved from intended location.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748988 ↗
InjurySep 14, 2026Migration
Device moved from intended location.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748985 ↗
InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487019 ↗
InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487018 ↗
InjuryAug 22, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50393063 ↗
InjuryAug 22, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50393062 ↗
InjuryAug 22, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50393057 ↗
InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863707 ↗
InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863688 ↗
InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25833638 ↗
InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832856 ↗
InjuryJul 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25831663 ↗
InjuryJul 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772200 ↗

Device details

UDI-DI	`07332747160918`
Brand	Replace Select™
Model	37311
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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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