simply InterActive® Implant 653713URecalls & reported problems

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

All models of simply InterActive Implant (23)

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

Quick summary

This simply InterActive implant has 230 adverse event reports, including 229 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone, along with problems with how it was positioned, and some describe infection and inflammation. No recalls name this device. Reports rose from 10 in the previous 12 months to 29 in the most recent 12 months.

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: 230
Deaths reported: 0
Injuries reported: 229
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 10841307106890), received between Aug 30, 2018 and Aug 25, 2026 — classified as 229 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (141 reports).

4 other recalls cover devices cleared under the same FDA submission (K130572); 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 Osseointegrate141
Positioning Failure27
Loss of Osseointegration25
Osseointegration Problem13
Positioning Problem13
Adverse Event Without Identified Device or Use Problem2
Device Appears to Trigger Rejection1
Device Slipped1

Patient problems

Failure of Implant187
Osteopenia/ Osteoporosis43
Inadequate Osseointegration36
Unspecified Infection33
Inflammation28
Pain27
Granuloma25
No Clinical Signs, Symptoms or Conditions22

Recent adverse event reports

The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.

InjuryAug 25, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50440193 ↗
InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 25693449 ↗
InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 25643845 ↗
InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Bruxism; Osteopenia/ Osteoporosis
MAUDE report 25642297 ↗
InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 25641661 ↗
InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 25628371 ↗
InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628329 ↗
InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25539705 ↗
InjuryMay 14, 2026Positioning Failure
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175162 ↗
InjuryApr 9, 2026Positioning Failure
LACK OF PRIMARY STABILITY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837618 ↗
InjuryApr 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24790120 ↗
InjuryMar 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24632054 ↗
InjuryJan 26, 2026Migration
PART MIGRATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24182983 ↗
InjuryJan 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24013077 ↗
InjuryJan 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24013009 ↗
InjuryDec 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23696060 ↗
InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23518318 ↗
InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23513163 ↗
InjuryNov 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23501713 ↗
InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483773 ↗
InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23482472 ↗
InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23475000 ↗
InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474642 ↗
InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474528 ↗
InjuryNov 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23474365 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130572. One submission often covers many models, so check the product and lot details in each record.

Z-0363-2020 · Oct 26, 2018 · Terminated
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Z-1917-2018 · Mar 14, 2018 · Terminated
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Produ
Z-0539-2018 · Jan 23, 2018 · Terminated
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Z-2551-2018 · Mar 3, 2017 · Terminated
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermedia

Device details

UDI-DI	`10841307106890`
Brand	simply InterActive® Implant
Model	653713U
Company	Implant Direct Sybron Manufacturing LLC
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K130572
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 13, 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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