simply RePlant ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 18 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 432
- Deaths reported
- 0
- Injuries reported
- 431
- Recalls
- 1
We found 18 models of simply RePlant Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 432 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2018 and Sep 11, 2026 — classified as 431 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (296 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
simply RePlant Implant recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 7, 2018Class IITerminated
The incorrect device was packaged in the vial.
Z-0010-2020 · Root cause: Employee error · Recall details · FDA record ↗
Most reported simply RePlant Implant problems
Device problems
- Failure to Osseointegrate296
- Loss of Osseointegration59
- Osseointegration Problem25
- Positioning Failure23
- Positioning Problem12
- Adverse Event Without Identified Device or Use Problem4
- Fracture4
- Migration3
Patient problems
- Failure of Implant385
- Unspecified Infection91
- Osteopenia/ Osteoporosis79
- Inflammation66
- No Consequences Or Impact To Patient46
- Inadequate Osseointegration42
- Pain42
- Granuloma41
simply RePlant Implant models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- simply RePlant® Implant 604310UImplant, Endosseous, Root-Form83 reports
- simply RePlant® Implant 605010UImplant, Endosseous, Root-Form73 reports
- simply RePlant® Implant 604313UImplant, Endosseous, Root-Form1 recall22 reports
- simply RePlant® Implant 603510UImplant, Endosseous, Root-Form45 reports
- simply RePlant® Implant 605008UImplant, Endosseous, Root-Form32 reports
- simply RePlant® Implant 604308UImplant, Endosseous, Root-Form31 reports
- simply RePlant® Implant 604311UImplant, Endosseous, Root-Form31 reports
- simply RePlant® Implant 603513UImplant, Endosseous, Root-Form30 reports
- simply RePlant® Implant 605011UImplant, Endosseous, Root-Form26 reports
- simply RePlant® Implant 603511UImplant, Endosseous, Root-Form17 reports
- simply RePlant® Implant 603508UImplant, Endosseous, Root-Form15 reports
- simply RePlant® Implant 605013UImplant, Endosseous, Root-Form13 reports
- simply RePlant® Implant 603516UImplant, Endosseous, Root-Form5 reports
- simply RePlant® Implant 606008UImplant, Endosseous, Root-Form3 reports
- simply RePlant® Implant 606010UImplant, Endosseous, Root-Form3 reports
- simply RePlant® Implant 605016UImplant, Endosseous, Root-Form1 report
- simply RePlant® Implant 606011UImplant, Endosseous, Root-Form1 report
- simply RePlant® Implant 606013UImplant, Endosseous, Root-Form1 report
Recent simply 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 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50734156 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50477418 ↗InjuryAug 18, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50307385 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50182186 ↗InjuryJun 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628350 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25164214 ↗InjuryApr 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916792 ↗InjuryJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24149277 ↗InjuryJan 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24131815 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23928119 ↗InjuryDec 24, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23889713 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483618 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462797 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462795 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461324 ↗
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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