NobelSpeedy® 32199Recalls & reported problems

Nobel Biocare AB · NOBELSPEEDY Replace NP 3.5x15mm · Class 2 · Implant

All models of NobelSpeedy (88)

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

Quick summary

This Nobel Biocare NobelSpeedy dental implant is placed in the jaw to support replacement teeth. The 26 reports mostly describe implants that did not bond with the bone and loosened or failed, sometimes with infection and pain. The reports mention 26 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: 26
Deaths reported: 0
Injuries reported: 26
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07332747001686), received between Dec 17, 2021 and Mar 19, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (22 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 Osseointegration22
Failure to Osseointegrate2
Osseointegration Problem2

Patient problems

Failure of Implant26
Pain4
Unspecified Infection4
Implant Pain2

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 21648335 ↗
InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 21648334 ↗
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 21428098 ↗
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant
MAUDE report 21427067 ↗
InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20717251 ↗
InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20716001 ↗
InjuryMay 3, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19242617 ↗
InjuryMay 3, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19242615 ↗
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19092621 ↗
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19092589 ↗
InjuryJul 20, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17366043 ↗
InjuryJul 20, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17366032 ↗
InjuryOct 11, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15575363 ↗
InjuryOct 10, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15571299 ↗
InjuryJul 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15046839 ↗
InjuryJul 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15046632 ↗
InjuryJul 15, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15032528 ↗
InjuryJul 15, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15032485 ↗
InjuryMay 23, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 14474224 ↗
InjuryMay 23, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 14474094 ↗
InjuryMay 20, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14457936 ↗
InjuryMay 20, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14457823 ↗
InjuryJan 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13195832 ↗
InjuryJan 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13195696 ↗
InjuryDec 17, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 13028166 ↗

Device details

UDI-DI	`07332747001686`
Brand	NobelSpeedy®
Model	32199
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.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
43,616 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
40,404 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
27,400 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,621 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,298 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,267 reports

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.

How reports and recalls are matched · Editorial policy · Report an error on this page