SwishPlus ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 338
- Deaths reported
- 0
- Injuries reported
- 291
- Recalls
- 0
We found 23 models of SwishPlus Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 338 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2017 and May 27, 2026 — classified as 291 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (185 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 SwishPlus Implant problems
Device problems
- Failure to Osseointegrate185
- Loss of Osseointegration54
- Device Misassembled During Manufacturing /Shipping43
- Osseointegration Problem18
- Positioning Failure16
- Positioning Problem7
- Device Appears to Trigger Rejection4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Failure of Implant273
- Osteopenia/ Osteoporosis56
- Inflammation52
- No Consequences Or Impact To Patient50
- Pain46
- Not Applicable43
- Unspecified Infection37
- Insufficient Information21
SwishPlus Implant models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SwishPlus® Implant 924110Implant, Endosseous, Root-Form73 reports
- SwishPlus® Implant 924108Implant, Endosseous, Root-Form33 reports
- 31 reports
- SwishPlus® Implant 924112Implant, Endosseous, Root-Form29 reports
- SwishPlus® Implant 924810Implant, Endosseous, Root-Form29 reports
- SwishPlus® Implant 923310Implant, Endosseous, Root-Form24 reports
- SwishPlus® Implant 924806Implant, Endosseous, Root-Form16 reports
- SwishPlus® Implant 924808Implant, Endosseous, Root-Form13 reports
- 12 reports
- SwishPlus® Implant 924814Implant, Endosseous, Root-Form11 reports
- SwishPlus® Implant 924106Implant, Endosseous, Root-Form10 reports
- 8 reports
- SwishPlus® Implant 923308Implant, Endosseous, Root-Form7 reports
- SwishPlus® Implant 923312Implant, Endosseous, Root-Form6 reports
- SwishPlus® Implant 924812Implant, Endosseous, Root-Form6 reports
- 6 reports
- SwishPlus® Implant 924116Implant, Endosseous, Root-Form5 reports
- 5 reports
- SwishPlus® Implant 924114Implant, Endosseous, Root-Form4 reports
- 4 reports
- 3 reports
- SwishPlus® Implant 923314Implant, Endosseous, Root-Form2 reports
- 1 report
Recent SwishPlus Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25304250 ↗InjuryMay 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25303409 ↗InjuryMar 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24724900 ↗InjuryMar 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24724261 ↗InjuryMar 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24724201 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200851 ↗InjuryJan 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23996762 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21519050 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FAILURE OF INTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20847955 ↗InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20847497 ↗InjuryAug 14, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19984682 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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