InterActive® Implant 653716Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10841307100423), received between Mar 26, 2019 and Jan 14, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Failure to Osseointegrate

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073960 ↗
• InjuryNov 30, 2022Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 15891317 ↗
• InjuryAug 9, 2022Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 15196472 ↗
• InjuryJul 25, 2022Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Fibrosis; Granuloma; Inflammation; Unspecified Infection

  MAUDE report 15093375 ↗
• InjuryApr 18, 2022Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 14139127 ↗
• InjuryApr 30, 2021Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Nerve Damage

  MAUDE report 11751312 ↗
• InjurySep 16, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 10539663 ↗
• InjuryJul 7, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS PER COMPLAINT (B)(4) A DENTAL IMPLANT DISPLAYED A FAILURE OF OSSEOINTEGRATION AND THE IMPLANT WAS EXPLANTED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 10239547 ↗
• InjuryFeb 7, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Fibrosis; Inflammation

  MAUDE report 9680251 ↗
• InjuryJan 14, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9585541 ↗
• InjuryNov 14, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 9320306 ↗
• InjurySep 27, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9129161 ↗
• InjurySep 10, 2019Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), PATIENT REPORTED PAIN AND SWELLING. DURING CLINICAL EXAMINATION IT WAS FOUND THAT IMPLANT DID NOT OSSEOINTEGRATE. IMPLANT WAS REMOVED.

  Patient problems: Failure of Implant; Impaired Healing; Inflammation; Pain

  MAUDE report 8979645 ↗
• InjuryMar 26, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PER COMPLAINT (B)(4) , AN INTRAORAL INFECTION WAS DISCOVERED WHEN THE PATIENT PRESENTED FOR A DENTAL IMPLANT CROWN IMPRESSION. THERE WAS PUS UPON BUCCAL PALPITATION. THE PATIENT WAS PRESENTED WITH THE OPTION OF LANAP TREATMENT WITH A PERIODONTIST OR IMPLANT REMOVAL. THE IMPLANT WAS REMOVED. INFLAMMATION AND OSTEOPENIA WERE ALSO REPORTED.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Purulent Discharge; Unspecified Infection

  MAUDE report 8453766 ↗

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