SwishActive™ Implant 944112Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10841307106678), received between Oct 28, 2020 and Apr 23, 2026 — classified as 15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 24972385 ↗
• InjuryApr 23, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 24972283 ↗
• InjuryMay 17, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 19345359 ↗
• InjuryJul 7, 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; Osteopenia/ Osteoporosis

  MAUDE report 14945264 ↗
• InjuryJul 6, 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; Unspecified Infection; Wound Dehiscence

  MAUDE report 14933140 ↗
• InjuryApr 29, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 14250115 ↗
• InjuryMar 7, 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; Granuloma; Inflammation

  MAUDE report 13685287 ↗
• InjuryFeb 21, 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; Unspecified Infection

  MAUDE report 13568818 ↗
• InjuryFeb 21, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Granuloma

  MAUDE report 13568803 ↗
• InjuryAug 6, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 12287098 ↗
• InjuryJul 22, 2021Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 12210489 ↗
• InjuryJul 5, 2021Positioning Failure; Positioning Failure

  PER COMPLAINT 73348, DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 12115407 ↗
• InjuryJan 25, 2021Positioning Problem; Positioning Problem

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

  Patient problems: Failure of Implant

  MAUDE report 11223003 ↗
• InjuryJan 22, 2021Positioning Problem; Positioning Problem

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

  Patient problems: Failure of Implant

  MAUDE report 11214788 ↗
• InjuryOct 28, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 10747111 ↗

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