RePlus ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 82
- Recalls
- 0
We found 16 models of RePlus Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Jul 30, 2018 and Jun 21, 2023 — classified as 82 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (47 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
Most reported RePlus Implant problems
Device problems
- Loss of Osseointegration47
- Failure to Osseointegrate28
- Adverse Event Without Identified Device or Use Problem5
- Osseointegration Problem2
- Positioning Problem2
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant83
- Osteopenia/ Osteoporosis26
- No Consequences Or Impact To Patient17
- Unspecified Infection16
- Inflammation11
- Impaired Healing7
- Insufficient Information5
- No Information5
RePlus Implant models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RePlus® Implant 703708Implant, Endosseous, Root-Form11 reports
- RePlus® Implant 703710Implant, Endosseous, Root-Form11 reports
- RePlus® Implant 703711Implant, Endosseous, Root-Form11 reports
- RePlus® Implant 704710Implant, Endosseous, Root-Form9 reports
- RePlus® Implant 704210Implant, Endosseous, Root-Form7 reports
- RePlus® Implant 704211Implant, Endosseous, Root-Form6 reports
- RePlus® Implant 703713Implant, Endosseous, Root-Form4 reports
- RePlus® Implant 704708Implant, Endosseous, Root-Form4 reports
- RePlus® Implant 704711Implant, Endosseous, Root-Form4 reports
- RePlus® Implant 705708Implant, Endosseous, Root-Form4 reports
- RePlus® Implant 704208Implant, Endosseous, Root-Form3 reports
- RePlus® Implant 704713Implant, Endosseous, Root-Form3 reports
- RePlus® Implant 705710Implant, Endosseous, Root-Form3 reports
- RePlus® Implant 705711Implant, Endosseous, Root-Form1 report
- RePlus® Implant 714708Implant, Endosseous, Root-Form1 report
- RePlus® Implant 715713Implant, Endosseous, Root-Form1 report
Recent RePlus Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 21, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17168408 ↗InjuryAug 2, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15146462 ↗InjuryAug 2, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT 83328, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 15146459 ↗InjuryJun 10, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 14654656 ↗InjuryApr 27, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 14219623 ↗InjuryFeb 15, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13539416 ↗InjuryJan 31, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 13397481 ↗InjuryNov 30, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12893014 ↗InjuryNov 22, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12852538 ↗InjuryOct 29, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12719554 ↗InjuryOct 27, 2021Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 12704188 ↗InjuryAug 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 12370451 ↗InjuryJul 13, 2021Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 12158755 ↗InjuryJun 24, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE
Patient problems: Failure of Implant; Granuloma; Unspecified Infection
MAUDE report 12057066 ↗InjuryJun 4, 2021Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FIT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 11937237 ↗
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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