NobelSpeedy® 32204Recalls & reported problems

Nobel Biocare AB · NOBELSPEEDY Replace RP 4x18mm · Class 2 · Implant

All models of NobelSpeedy (88)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This NobelSpeedy Replace root-form dental implant is a small screw-like implant used to anchor a replacement tooth in the jawbone. The 50 reports mostly describe the implant not bonding with the surrounding bone, so it becomes loose or has to be removed, along with pain, numbness and infection;50 reports describe 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: 50
Deaths reported: 0
Injuries reported: 50
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 07332747001730), received between Nov 19, 2021 and Apr 7, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (40 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Loss of Osseointegration40
Failure to Osseointegrate8
Fracture2

Patient problems

Failure of Implant36
Pain10
Numbness8
Unspecified Infection6
Inflammation4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inflammation
MAUDE report 24810265 ↗
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24810200 ↗
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inflammation
MAUDE report 24810169 ↗
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24810138 ↗
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24810132 ↗
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inflammation
MAUDE report 24810076 ↗
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inflammation
MAUDE report 24810071 ↗
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24810047 ↗
InjuryDec 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929726 ↗
InjuryDec 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929704 ↗
InjurySep 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22988274 ↗
InjurySep 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22988268 ↗
InjuryAug 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 22881066 ↗
InjuryAug 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 22881064 ↗
InjuryJul 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19735073 ↗
InjuryJul 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19734856 ↗
InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19054441 ↗
InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19054108 ↗
InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18890408 ↗
InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18890399 ↗
InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18890378 ↗
InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18890344 ↗
InjuryDec 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 18413524 ↗
InjuryDec 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 18413517 ↗
InjuryDec 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 18413515 ↗

Device details

UDI-DI	`07332747001730`
Brand	NobelSpeedy®
Model	32204
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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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