SwishPlus® Implant 924806Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 16
Deaths reported: 0
Injuries reported: 6
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10841307106180), received between Dec 18, 2017 and Nov 3, 2025 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (10 reports).

3 other recalls cover devices cleared under the same FDA submission (K081396); they may or may not involve this specific model.

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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Device Misassembled During Manufacturing /Shipping10
Failure to Osseointegrate5
Osseointegration Problem1

Patient problems

Not Applicable10
Failure of Implant6
Osteopenia/ Osteoporosis2
Insufficient Information1
Unspecified Infection1

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 23448901 ↗
InjuryApr 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 16815365 ↗
InjuryApr 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 16815355 ↗
InjuryJan 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4) , AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 16231172 ↗
InjuryJan 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11247109 ↗
InjuryJan 22, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11214773 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125820 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125817 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125815 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125788 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125784 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125776 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125750 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125749 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125743 ↗
MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081396. One submission often covers many models, so check the product and lot details in each record.

Z-1126-2020 · Jan 9, 2019 · Terminated
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Z-1168-2018 · Jan 19, 2018 · Terminated
SwishPlus Implant Intended for use in support for fixed bridgework.
Z-0396-2016 · Oct 28, 2015 · Terminated
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable

Device details

UDI-DI	`10841307106180`
Brand	SwishPlus® Implant
Model	924806
Company	Implant Direct Sybron Manufacturing LLC
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K081396
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 20, 2024

Device type (GMDN): Dental implant system

A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Other Implant, Endosseous, Root-Form devices

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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