simply RePlant® Implant 604313URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.3 x 13 Platform 4.3mmD · Class 2 · Implant
All models of simply RePlant Implant (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10841307108313), received between Jul 26, 2018 and Oct 3, 2024 — classified as 21 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (12 reports).
1 FDA recall record name this device's identifier.
3 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
Recalls naming this device
- 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 problems
Device problems
- Failure to Osseointegrate12
- Adverse Event Without Identified Device or Use Problem2
- Osseointegration Problem2
- Positioning Failure2
- Positioning Problem2
- Device Markings/Labelling Problem1
- Loss of Osseointegration1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Failure of Implant21
- No Consequences Or Impact To Patient5
- Unspecified Infection5
- Fibrosis3
- Inflammation3
- Pain3
- Granuloma2
- Insufficient Information2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2024Osseointegration Problem; Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 20362568 ↗InjurySep 8, 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; Fibrosis; Granuloma
MAUDE report 17710842 ↗InjuryOct 19, 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; Insufficient Information
MAUDE report 15636655 ↗InjuryJun 29, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 14853938 ↗InjuryMar 17, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Granuloma; Unspecified Infection; Wound Dehiscence
MAUDE report 13801153 ↗InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration
(B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 13564733 ↗InjuryJan 5, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 13168804 ↗InjurySep 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; Insufficient Information
MAUDE report 12525536 ↗InjuryMar 30, 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; Unspecified Infection
MAUDE report 11588175 ↗InjuryJan 15, 2021Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Inflammation; Unspecified Infection
MAUDE report 11177598 ↗InjuryMar 27, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Abscess; Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 9889616 ↗InjuryFeb 5, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9669638 ↗InjuryOct 15, 2019Failure 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 9190230 ↗InjuryOct 1, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9138742 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), A PATIENT'S DENTAL IMPLANT FAILED TO OSSEOINTEGRATE. THE IMPLANT WAS REMOVED FOUR MONTHS AFTER INITIAL PLACEMENT. FIBROUS TISSUE WAS REPORTED TO BE AROUND THE IMPLANT.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 9045576 ↗InjurySep 13, 2019Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9022085 ↗InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8979571 ↗InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8976640 ↗InjuryAug 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER COMPLAINT (B)(4), THE AREA AROUND A PATIENT'S DENTAL IMPLANT BECAME INFECTED. THE IMPLANT HAD TO BE REMOVED AND WAS EXPLANTED THREE WEEKS AFTER INITIAL PLACEMENT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 8881626 ↗InjuryOct 10, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
PER COMPLAINT (B)(4), IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN. THEIR DENTAL IMPLANT WAS EXPLANTED.
Patient problems: Failure of Implant; Pain
MAUDE report 7952371 ↗InjuryAug 15, 2018Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), THE IMPLANT WAS SPINNING WITH NO INTEGRATION DURING THE IMPLANTATION PROCESS. UPON REMOVING THE IMPLANT, IT WAS DISCOVERED THAT THE BUCCAL PLATE HAD BEEN PERFORATED. A BONE GRAFT/MEMBRANE WAS PLACED.
Patient problems: Failure of Implant; Perforation
MAUDE report 7787465 ↗MalfunctionJul 26, 2018Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
PER (B)(4), THERE WAS A PACKAGING ERROR. IN THE VIAL THERE WAS WHAT APPEARED TO BE AN ABUTMENT INSTEAD OF AN IMPLANT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 7723419 ↗
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-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
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- 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 · each recall links to the FDA recall notice
- 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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