InterActive 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
- 1,609
- Deaths reported
- 0
- Injuries reported
- 1,572
- Recalls
- 0
We found 23 models of InterActive Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 1,609 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2017 and Sep 30, 2026 — classified as 1,572 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (931 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 InterActive Implant problems
Device problems
- Failure to Osseointegrate931
- Loss of Osseointegration227
- Osseointegration Problem133
- Positioning Failure106
- Positioning Problem101
- Separation Failure36
- Fracture18
- Malposition of Device16
Patient problems
- Failure of Implant1,438
- Osteopenia/ Osteoporosis310
- Inflammation230
- Unspecified Infection229
- Pain205
- No Consequences Or Impact To Patient171
- Granuloma141
- Inadequate Osseointegration120
InterActive Implant models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- InterActive® Implant 654310Implant, Endosseous, Root-Form198 reports
- InterActive® Implant 654311Implant, Endosseous, Root-Form163 reports
- InterActive® Implant 653710Implant, Endosseous, Root-Form160 reports
- InterActive® Implant 655010Implant, Endosseous, Root-Form153 reports
- InterActive® Implant 653711Implant, Endosseous, Root-Form119 reports
- InterActive® Implant 653210Implant, Endosseous, Root-Form110 reports
- InterActive® Implant 655008Implant, Endosseous, Root-Form95 reports
- InterActive® Implant 654308Implant, Endosseous, Root-Form89 reports
- InterActive® Implant 654313Implant, Endosseous, Root-Form67 reports
- InterActive® Implant 653211Implant, Endosseous, Root-Form63 reports
- InterActive® Implant 653713Implant, Endosseous, Root-Form63 reports
- InterActive® Implant 655011Implant, Endosseous, Root-Form63 reports
- InterActive® Implant 653708Implant, Endosseous, Root-Form56 reports
- InterActive® Implant 653208Implant, Endosseous, Root-Form50 reports
- InterActive® Implant 653213Implant, Endosseous, Root-Form46 reports
- InterActive® Implant 655013Implant, Endosseous, Root-Form30 reports
- 18 reports
- InterActive® Implant 654316Implant, Endosseous, Root-Form15 reports
- InterActive® Implant 653716Implant, Endosseous, Root-Form14 reports
- 13 reports
- InterActive® Implant 653216Implant, Endosseous, Root-Form10 reports
- 10 reports
- InterActive® Implant 655016Implant, Endosseous, Root-Form4 reports
Recent InterActive Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50952927 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50952910 ↗InjurySep 28, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923019 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50830886 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 50830566 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50830087 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50829763 ↗InjurySep 15, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50774434 ↗InjuryAug 18, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 50311432 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50262067 ↗InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50261366 ↗InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50261009 ↗InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50260820 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page