SwishActive ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 231
- Deaths reported
- 0
- Injuries reported
- 229
- Recalls
- 0
We found 12 models of SwishActive Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 231 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2018 and Jul 8, 2026 — classified as 229 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (140 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SwishActive Implant problems
Device problems
- Failure to Osseointegrate140
- Loss of Osseointegration44
- Osseointegration Problem20
- Positioning Failure12
- Positioning Problem7
- Separation Failure3
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Insert2
Patient problems
- Failure of Implant206
- Unspecified Infection64
- Inflammation62
- Osteopenia/ Osteoporosis58
- Pain27
- Granuloma26
- Inadequate Osseointegration19
- Impaired Healing17
SwishActive Implant models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SwishActive™ Implant 944110Implant, Endosseous, Root-Form69 reports
- SwishActive™ Implant 944810Implant, Endosseous, Root-Form31 reports
- SwishActive™ Implant 943310Implant, Endosseous, Root-Form29 reports
- SwishActive™ Implant 944108Implant, Endosseous, Root-Form29 reports
- SwishActive™ Implant 943312Implant, Endosseous, Root-Form16 reports
- SwishActive™ Implant 944808Implant, Endosseous, Root-Form16 reports
- SwishActive™ Implant 944112Implant, Endosseous, Root-Form15 reports
- SwishActive™ Implant 943308Implant, Endosseous, Root-Form9 reports
- SwishActive™ Implant 944812Implant, Endosseous, Root-Form7 reports
- SwishActive™ Implant 944106Implant, Endosseous, Root-Form4 reports
- SwishActive™ Implant 944114Implant, Endosseous, Root-Form4 reports
- SwishActive™ Implant 944806Implant, Endosseous, Root-Form2 reports
Recent SwishActive Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25754115 ↗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 ↗InjuryFeb 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24326892 ↗InjuryJan 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24215381 ↗InjuryNov 7, 2025Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert
InjuryNov 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23475019 ↗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
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 23461298 ↗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 21767864 ↗InjuryApr 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21767851 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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