SwishActive™ Implant 943308Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841307106593), received between Sep 11, 2019 and Jul 26, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2023Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(6), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17394820 ↗
• InjuryJan 11, 2023Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 16136215 ↗
• InjuryJan 11, 2023Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 16136210 ↗
• InjuryJan 28, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 11247121 ↗
• InjuryJan 22, 2021Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11214714 ↗
• InjuryMar 17, 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; Osteopenia/ Osteoporosis

  MAUDE report 9840868 ↗
• 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; Pain; Unspecified Infection

  MAUDE report 9840840 ↗
• InjuryDec 13, 2019Positioning 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 9465239 ↗
• InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), THE PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE. IMPLANT WAS REMOVED AND APPLIED COLLAGEN PLUG.

  Patient problems: Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 8987268 ↗

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