RePlant® Implant 603508Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of RePlant Implant (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct RePlant dental implant is a tooth implant placed in the jawbone. Its 104 reports, 102 of them injuries, mostly describe the implant failing to fuse with the bone, with some reporting infection, pain and inflammation. There were no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 104
- Deaths reported
- 0
- Injuries reported
- 102
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10841307103981), received between Sep 12, 2018 and Jan 12, 2026 — classified as 102 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (64 reports).
4 other recalls cover devices cleared under the same FDA submission (K061319); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate64
- Loss of Osseointegration18
- Osseointegration Problem7
- Patient Device Interaction Problem4
- Device Slipped3
- Positioning Problem3
- Separation Failure2
- Device Appears to Trigger Rejection1
Patient problems
- Failure of Implant91
- Unspecified Infection24
- Pain19
- Osteopenia/ Osteoporosis18
- Inflammation14
- No Consequences Or Impact To Patient12
- Inadequate Osseointegration10
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24032171 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474447 ↗InjuryMar 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21658572 ↗InjuryJun 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19569045 ↗InjuryJun 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19569025 ↗InjuryJun 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19569016 ↗InjuryMay 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19262769 ↗InjuryApr 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 2, 2024Premature Separation; Premature Separation
PART NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18823334 ↗InjuryFeb 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17593098 ↗InjuryAug 4, 2023Device Slipped; Device Slipped
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DROPPED FROM IMPLANT DRIVER.
Patient problems: Failure of Implant
MAUDE report 17459199 ↗InjuryJul 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17394826 ↗InjuryJul 14, 2023Failure 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
MAUDE report 17323860 ↗InjuryJul 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17247773 ↗InjuryJun 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17056985 ↗InjuryMay 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16854805 ↗InjuryJan 11, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 16136216 ↗InjuryJan 10, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16128803 ↗InjuryNov 15, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4) AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 15796691 ↗InjuryNov 4, 2022Device Slipped; Device Slipped
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, IMPLANT DROPPED FROM THE IMPLANT DRIVER.
Patient problems: Failure of Implant
MAUDE report 15731806 ↗InjuryNov 4, 2022Device Slipped; Device Slipped
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, IMPLANT DROPPED FROM THE IMPLANT DRIVER.
Patient problems: Failure of Implant
MAUDE report 15731469 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061319. One submission often covers many models, so check the product and lot details in each record.
- Z-0010-2020 · Aug 7, 2018 · TerminatedImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousa
- Z-2376-2018 · May 18, 2018 · TerminatedREPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Z-2125-2017 · May 2, 2017 · TerminatedLegacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
- Z-2320-2016 · Jul 5, 2016 · TerminatedRePlant Angled Abutment Part Number 6050-52-60
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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