InterActive® Implant 654311Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.3 x 11.5 Platform 3.4mmD (RP) Conical · Class 2 · Implant
Quick summary
This Implant Direct InterActive implant is a dental implant placed in the jawbone. Reports mostly describe implants that did not fuse with the bone or lacked stability during placement, and some describe the implant moving out of position. The 159 reports include no deaths and 157 injuries. 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
- 163
- Deaths reported
- 0
- Injuries reported
- 161
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 10841307100461), received between Aug 3, 2018 and Sep 18, 2026 — classified as 161 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (90 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 Osseointegrate90
- Loss of Osseointegration25
- Positioning Failure17
- Osseointegration Problem12
- Positioning Problem6
- Malposition of Device4
- Adverse Event Without Identified Device or Use Problem3
- Separation Failure3
Patient problems
- Failure of Implant139
- Osteopenia/ Osteoporosis31
- Unspecified Infection28
- Inflammation21
- Pain21
- No Consequences Or Impact To Patient20
- Inadequate Osseointegration16
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 25 most recent of 163 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 50830886 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 50830566 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50830087 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50829763 ↗InjuryApr 28, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018029 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 24, 2026Positioning Failure; Migration
PART MIGRATES.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24677311 ↗InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24161515 ↗InjuryJan 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23982624 ↗InjuryDec 8, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737967 ↗InjuryNov 28, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675542 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Granuloma; Inadequate Osseointegration
MAUDE report 23483775 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Granuloma; Inadequate Osseointegration
MAUDE report 23483769 ↗InjuryNov 5, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
HYGIENE AROUND IMPLANT: GOOD; BONE QUALITY: TYPE II (MEDIUM/HARD BONE).
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23475032 ↗InjuryNov 4, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461523 ↗InjuryOct 31, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 23436747 ↗InjuryFeb 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 31, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21021745 ↗InjuryDec 12, 2024Malposition of Device; Malposition of Device
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919811 ↗InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20571810 ↗InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20571792 ↗InjurySep 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20304843 ↗InjuryMay 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
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.