RePlant ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,351
- Deaths reported
- 0
- Injuries reported
- 2,327
- Recalls
- 0
We found 20 models of RePlant Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 2,351 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2018 and Sep 15, 2026 — classified as 2,327 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,297 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 RePlant Implant problems
Device problems
- Failure to Osseointegrate1,297
- Loss of Osseointegration708
- Osseointegration Problem112
- Positioning Failure65
- Positioning Problem53
- Fracture36
- Adverse Event Without Identified Device or Use Problem24
- Separation Failure21
Patient problems
- Failure of Implant2,021
- Osteopenia/ Osteoporosis584
- Inflammation381
- Unspecified Infection372
- Inadequate Osseointegration294
- No Consequences Or Impact To Patient269
- Pain261
- No Clinical Signs, Symptoms or Conditions259
RePlant Implant models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RePlant® Implant 604310Implant, Endosseous, Root-Form398 reports
- RePlant® Implant 605010Implant, Endosseous, Root-Form310 reports
- RePlant® Implant 603510Implant, Endosseous, Root-Form291 reports
- RePlant® Implant 604313Implant, Endosseous, Root-Form232 reports
- RePlant® Implant 604311Implant, Endosseous, Root-Form180 reports
- RePlant® Implant 603513Implant, Endosseous, Root-Form158 reports
- RePlant® Implant 603511Implant, Endosseous, Root-Form142 reports
- RePlant® Implant 604308Implant, Endosseous, Root-Form138 reports
- RePlant® Implant 605011Implant, Endosseous, Root-Form110 reports
- RePlant® Implant 603508Implant, Endosseous, Root-Form104 reports
- RePlant® Implant 605008Implant, Endosseous, Root-Form97 reports
- RePlant® Implant 605013Implant, Endosseous, Root-Form81 reports
- RePlant® Implant 604316Implant, Endosseous, Root-Form26 reports
- RePlant® Implant 603516Implant, Endosseous, Root-Form25 reports
- RePlant® Implant 606010Implant, Endosseous, Root-Form25 reports
- RePlant® Implant 606011Implant, Endosseous, Root-Form11 reports
- RePlant® Implant 606008Implant, Endosseous, Root-Form9 reports
- RePlant® Implant 605016Implant, Endosseous, Root-Form7 reports
- RePlant® Implant 606013Implant, Endosseous, Root-Form6 reports
- RePlant® Implant 606016Implant, Endosseous, Root-Form1 report
Recent RePlant Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50775289 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50475570 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50331424 ↗InjuryAug 18, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50308023 ↗InjuryAug 18, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50308022 ↗InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50238395 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50216461 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50216306 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50216147 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50216106 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50203078 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50147258 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50147119 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50146967 ↗InjuryJul 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50091419 ↗
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
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
- InterActive Implant23 models · 1,609 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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