simply RePlant® Implant 605011URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.0 x 11.5 Platform 5.0mmD · Class 2 · Implant
All models of simply RePlant Implant (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This simply RePlant dental implant is a root-form implant placed in the jawbone. Reports mainly describe the implant failing to bond with bone, losing stability, or being used incorrectly. There are 26 adverse event reports, with no deaths and 26 injuries; 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10841307108351), received between Sep 10, 2019 and Dec 24, 2025 — classified as 26 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Loss of Osseointegration6
- Osseointegration Problem2
- Positioning Failure2
- Labelling, Instructions for Use or Training Problem1
Patient problems
- Failure of Implant23
- Osteopenia/ Osteoporosis8
- No Consequences Or Impact To Patient5
- Unspecified Infection4
- Granuloma3
- Inadequate Osseointegration3
- No Clinical Signs, Symptoms or Conditions3
- Fibrosis2
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryOct 31, 2025Osseointegration Problem; Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436505 ↗InjuryMay 16, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 16938141 ↗InjuryJan 12, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 16145824 ↗InjurySep 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 15336464 ↗InjuryAug 26, 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; Granuloma; Inflammation; Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 15301137 ↗InjuryApr 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 14022312 ↗InjuryMar 7, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 13685331 ↗InjuryJan 11, 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
MAUDE report 13226166 ↗InjuryAug 17, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Granuloma; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 12330890 ↗InjuryJul 27, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Granuloma; Osteopenia/ Osteoporosis
MAUDE report 12232582 ↗InjuryJul 5, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12115361 ↗InjuryJun 10, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 11974180 ↗InjuryApr 19, 2021Loss of Osseointegration; Loss of Osseointegration
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11685227 ↗InjuryApr 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11685222 ↗InjuryOct 15, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 10684118 ↗InjuryDec 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9501823 ↗InjuryNov 6, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 9283267 ↗InjuryOct 1, 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; Osteopenia/ Osteoporosis
MAUDE report 9138750 ↗InjurySep 27, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9129264 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, IT WAS OBSERVED THAT PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9022223 ↗InjurySep 11, 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; No Consequences Or Impact To Patient
MAUDE report 8987206 ↗InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING UNCOVERING, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8979708 ↗InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE AND CAUSED BONELOSS AT THE THIRD THREAD.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 8979702 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page