ScrewIndirect® Implant 403710Recalls & reported problems

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

All models of ScrewIndirect Implant (13)

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

Quick summary

This Implant Direct ScrewIndirect is a dental implant placed in the jawbone to hold a replacement tooth. Its 241 reports mostly describe the implant failing to fuse with the jawbone, with some describing inflammation, infection or a granuloma (a small inflammatory lump) around it. The reports include 241 injuries and no deaths, and they rose from 11 in the prior 12 months to 47 in the last 12 months. 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: 241
Deaths reported: 0
Injuries reported: 241
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 241 adverse event reports that list this exact device (DI 10841307104766), received between Aug 28, 2019 and Jun 25, 2026 — classified as 241 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (154 reports).

4 other recalls cover devices cleared under the same FDA submission (K061319); 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Osseointegrate154
Positioning Failure37
Osseointegration Problem17
Loss of Osseointegration9
Adverse Event Without Identified Device or Use Problem7
Positioning Problem7
Difficult to Insert5
Labelling, Instructions for Use or Training Problem3

Patient problems

Failure of Implant173
No Clinical Signs, Symptoms or Conditions59
Inadequate Osseointegration56
Inflammation27
Granuloma20
Unspecified Infection17
No Consequences Or Impact To Patient14
Pain14

Recent adverse event reports

The 25 most recent of 241 reports, in the reporter's own words as published by the FDA.

InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631357 ↗
InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631355 ↗
InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628324 ↗
InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25186954 ↗
InjuryApr 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24993959 ↗
InjuryApr 21, 2026Fracture
PART FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940440 ↗
InjuryApr 20, 2026Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24927759 ↗
InjuryApr 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24927127 ↗
InjuryApr 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926867 ↗
InjuryApr 17, 2026Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916827 ↗
InjuryApr 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24841055 ↗
InjuryApr 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24810980 ↗
InjuryApr 5, 2026Difficult to Insert
COMPONENT DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787111 ↗
InjuryMar 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24721080 ↗
InjuryFeb 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24291867 ↗
InjuryJan 29, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24209578 ↗
InjuryJan 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24131567 ↗
InjuryJan 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24131518 ↗
InjuryJan 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24029040 ↗
InjuryJan 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24029039 ↗
InjuryDec 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23840320 ↗
InjuryDec 10, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23772238 ↗
InjuryDec 3, 2025Malposition of Device; Malposition of Device
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707162 ↗
InjuryDec 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23689115 ↗
InjuryNov 26, 2025Difficult to Insert; Difficult to Insert
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23661448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061319. One submission often covers many models, so check the product and lot details in each record.

Z-0010-2020 · Aug 7, 2018 · Terminated
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousa
Z-2376-2018 · May 18, 2018 · Terminated
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Z-2125-2017 · May 2, 2017 · Terminated
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Z-2320-2016 · Jul 5, 2016 · Terminated
RePlant Angled Abutment Part Number 6050-52-60

Device details

UDI-DI	`10841307104766`
Brand	ScrewIndirect® Implant
Model	403710
Company	Implant Direct Sybron Manufacturing LLC
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K061319
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.

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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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