NobelSpeedy® 32192Recalls & reported problems

Nobel Biocare AB · NOBELSPEEDY Replace 6.0 6x11.5mm · Class 2 · Implant

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

Quick summary

This NobelSpeedy 32192 is a root-form dental implant used to replace missing teeth. The 52 reports mostly describe the implant failing to bond with the surrounding jawbone, so it becomes loose or has to be removed; reports also mention infections, pain, and sinus perforation. There are no deaths and 52 injuries, and 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: 52
Deaths reported: 0
Injuries reported: 52
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 07332747001617), received between Nov 9, 2021 and Aug 25, 2026 — classified as 52 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (44 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 Osseointegration44
Failure to Osseointegrate6
Osseointegration Problem2

Patient problems

Failure of Implant46
Unspecified Infection10
Pain8
No Clinical Signs, Symptoms or Conditions6
Implant Pain2
Sinus Perforation2

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

InjuryAug 25, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440600 ↗
InjuryAug 25, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440597 ↗
InjuryApr 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783787 ↗
InjuryApr 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782865 ↗
InjuryJul 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22377781 ↗
InjuryJul 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22377779 ↗
InjuryApr 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21748173 ↗
InjuryApr 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21748171 ↗
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 21500750 ↗
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 21500749 ↗
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 21416043 ↗
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 21416014 ↗
InjuryFeb 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 21328308 ↗
InjuryFeb 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 21328307 ↗
InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 21193669 ↗
InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 21193668 ↗
InjuryOct 9, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20412077 ↗
InjuryOct 9, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20411541 ↗
InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19725779 ↗
InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19725513 ↗
InjuryApr 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19092554 ↗
InjuryApr 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19092544 ↗
InjurySep 28, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17839337 ↗
InjurySep 28, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17839314 ↗
InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17811589 ↗

Device details

UDI-DI	`07332747001617`
Brand	NobelSpeedy®
Model	32192
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 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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