Replace Select™ 29414 (UDI 07332747159684)Recalls & reported problems

Nobel Biocare AB · Replace Select™ Tapered TiU RP 4.3x13mm · Class 2 · Implant

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

Quick summary

This Nobel Biocare Replace Select root-form implant is placed in bone. Most of the 1,366 reports describe the implant failing to bond with the bone or losing that bond, and some mention infection, pain or an abscess. The reports include no deaths and 1,354 injuries. 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: 1,378
Deaths reported: 0
Injuries reported: 1,366
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1,378 adverse event reports that list this exact device (DI 07332747159684), received between Oct 29, 2021 and Sep 30, 2026 — classified as 1,366 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (636 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 Osseointegrate636
Loss of Osseointegration607
Osseointegration Problem65
Fracture34
Adverse Event Without Identified Device or Use Problem18
Defective Device6
Migration6
Premature Separation4

Patient problems

Failure of Implant790
No Clinical Signs, Symptoms or Conditions375
Unspecified Infection157
Pain76
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available67
Abscess20
Numbness18
Implant Pain10

Recent adverse event reports

The 25 most recent of 1,378 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954016 ↗
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954015 ↗
InjurySep 30, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50953076 ↗
InjurySep 30, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50953074 ↗
InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780992 ↗
InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780989 ↗
InjurySep 8, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50678422 ↗
InjurySep 8, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50678418 ↗
InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463803 ↗
InjuryAug 26, 2026Failure to Osseointegrate
Failure to Osseo integrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463802 ↗
InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463801 ↗
InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463798 ↗
InjuryAug 25, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441125 ↗
InjuryAug 25, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441124 ↗
InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382705 ↗
InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358680 ↗
InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358676 ↗
InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50333302 ↗
InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262592 ↗
InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262588 ↗
InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Implant Pain
MAUDE report 50262428 ↗
InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Implant Pain
MAUDE report 50262424 ↗
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228358 ↗
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228356 ↗
InjuryAug 5, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50149847 ↗

Device details

UDI-DI	`07332747159684`
Brand	Replace Select™
Model	29414
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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