simply InterActive® Implant 654310URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
Quick summary
This Implant Direct simply InterActive dental implant is placed in the jawbone. Its 645 reports mostly describe the implant failing to bond with the surrounding bone, with some reports of inflammation and infection. The reports include 638 injuries and no deaths, and they rose from 37 in the previous 12 months to 77 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
- 645
- Deaths reported
- 0
- Injuries reported
- 638
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 645 adverse event reports that list this exact device (DI 10841307106937), received between Jan 3, 2019 and Sep 18, 2026 — classified as 638 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (417 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate417
- Loss of Osseointegration78
- Positioning Failure54
- Osseointegration Problem38
- Positioning Problem33
- Separation Failure6
- Adverse Event Without Identified Device or Use Problem5
- Premature Separation5
Patient problems
- Failure of Implant517
- Inflammation112
- Inadequate Osseointegration109
- Osteopenia/ Osteoporosis108
- Unspecified Infection99
- No Clinical Signs, Symptoms or Conditions85
- Pain82
- Granuloma70
Recent adverse event reports
The 25 most recent of 645 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50831083 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50485333 ↗InjuryAug 20, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50355858 ↗InjuryAug 17, 2026Loss of Osseointegration
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50280818 ↗InjuryAug 17, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50278161 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50229472 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50228948 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration
MAUDE report 50223630 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50223421 ↗InjuryJul 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50077119 ↗InjuryJul 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50076911 ↗InjuryJun 24, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25613944 ↗InjuryJun 8, 2026Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25428844 ↗InjuryJun 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25410325 ↗InjuryMay 26, 2026Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25284710 ↗InjuryMay 26, 2026Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25284216 ↗InjuryMay 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25260038 ↗InjuryMay 22, 2026Inadequacy of Device Shape and/or Size; Failure to Osseointegrate
IMPLANT/ABUTMENT PARTIALLY VISIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25259002 ↗InjuryMay 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25256064 ↗InjuryMay 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25255678 ↗InjuryMay 14, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175036 ↗InjuryMay 8, 2026Positioning Failure; Osseointegration Problem
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25129783 ↗InjuryApr 28, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016158 ↗InjuryApr 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24926367 ↗InjuryApr 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916712 ↗
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 · TerminatedImplant 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 · TerminatedImplantDirect 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 · TerminatedImplant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- Z-2551-2018 · Mar 3, 2017 · TerminatedImplantDirect, 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
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.