SwishActive™ Implant 943312Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10841307106616), received between Nov 6, 2019 and Oct 29, 2021 — classified as 16 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2021Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 12719564 ↗
• 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 12287100 ↗
• InjuryMay 27, 2021Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 11893502 ↗
• InjuryFeb 12, 2021Failure 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; Unspecified Infection

  MAUDE report 11321436 ↗
• InjuryJan 22, 2021Loss of Osseointegration; Loss of Osseointegration

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

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

  MAUDE report 11214825 ↗
• InjuryJan 22, 2021Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11214747 ↗
• InjuryNov 20, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 10874473 ↗
• InjuryOct 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; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 10642477 ↗
• InjuryJun 25, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER (B)(4), THE DENTAL IMPLANT FAILED TO INTEGRATE. PATIENT EXPERIENCED INFLAMMATION AND FIBROUS TISSUE.

  Patient problems: Failure of Implant; Fibrosis; Inflammation

  MAUDE report 10197821 ↗
• InjuryMar 31, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 9902343 ↗
• InjuryMar 19, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Organ Dehiscence; Pain; Unspecified Infection

  MAUDE report 9852677 ↗
• InjuryMar 18, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 9847225 ↗
• InjuryMar 18, 2020Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 9847219 ↗
• InjuryMar 6, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9800397 ↗
• InjuryDec 13, 2019Failure 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; Osteopenia/ Osteoporosis

  MAUDE report 9464653 ↗
• InjuryNov 6, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 9283262 ↗

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