SwishActive™ Implant 944812Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307106739), received between May 8, 2018 and Nov 4, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23461298 ↗
• InjuryNov 17, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 12828705 ↗
• InjuryJul 27, 2021Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Granuloma; Unspecified Infection

  MAUDE report 12232450 ↗
• InjuryJun 10, 2021Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Wound Dehiscence

  MAUDE report 11974183 ↗
• InjuryMar 19, 2020Positioning Problem; Positioning Problem

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

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

  MAUDE report 9852673 ↗
• InjuryMar 17, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 9840804 ↗
• InjuryMay 8, 2018Fracture; Fracture

  THE ABUTMENT SCREW BROKE AND CAUSED THE IMPLANT TO FAIL. IMPLANT WAS REMOVED, REQUIRING MEDICAL INTERVENTION. THIS IS A REPORTABLE SERIOUS INJURY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7497234 ↗

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