SwishActive™ Implant 944110Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of SwishActive Implant (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This SwishActive dental implant is a small screw-shaped titanium post used as a root replacement in jawbone surgery. Most of the 69 reports describe the implant failing to fuse with the surrounding bone or losing that bond after placement, along with inflammation, infection, and slow healing; 68 injuries and no deaths are reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10841307106661), received between Jul 29, 2019 and Nov 7, 2025 — classified as 68 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (42 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate42
- Loss of Osseointegration16
- Osseointegration Problem4
- Positioning Problem3
- Difficult to Insert2
- Positioning Failure2
- Nonstandard Device1
- Separation Failure1
Patient problems
- Failure of Implant57
- Inflammation19
- Osteopenia/ Osteoporosis17
- Unspecified Infection17
- Impaired Healing13
- Inadequate Osseointegration9
- No Clinical Signs, Symptoms or Conditions7
- Pain7
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2025Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert
InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474590 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2025Separation Failure; Separation Failure
PART/INTERFACE DOES NOT DISENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461090 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23449184 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21767835 ↗InjuryMar 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21725329 ↗InjuryMar 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 21658604 ↗InjuryFeb 11, 2025Difficult to Insert; Failure to Osseointegrate; Difficult to Insert; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21359051 ↗InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE OF INTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20859721 ↗InjuryNov 13, 2024Osseointegration Problem; Osseointegration Problem
OTHER PRODUCT DEFICIENCIES AND TECHNICAL.
Patient problems: Failure of Implant
MAUDE report 20678537 ↗InjuryOct 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20421146 ↗InjuryAug 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 17168405 ↗InjuryJun 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 17168402 ↗InjuryJan 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4) , DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16202507 ↗InjuryFeb 18, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Granuloma; Unspecified Infection
MAUDE report 13564717 ↗InjuryDec 14, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 13006937 ↗InjuryDec 14, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 13006933 ↗InjuryDec 14, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 13006921 ↗InjuryNov 30, 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; Inflammation; Pain
MAUDE report 12893082 ↗InjuryOct 27, 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
MAUDE report 12704218 ↗InjurySep 23, 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 12518977 ↗InjurySep 13, 2021Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 12460237 ↗
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 · TerminatedImplant 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 · TerminatedImplantDirect 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 · TerminatedImplant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- Z-2551-2018 · Mar 3, 2017 · TerminatedImplantDirect, 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
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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