simply RePlant® Implant 605013URecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10841307108368), received between Sep 11, 2019 and Sep 4, 2023 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (11 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(6) AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 17676693 ↗
• InjuryFeb 27, 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; Osteopenia/ Osteoporosis

  MAUDE report 16449382 ↗
• InjuryFeb 27, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 16444969 ↗
• InjuryApr 12, 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

  MAUDE report 14086085 ↗
• InjuryMay 25, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 11877211 ↗
• InjuryMay 25, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11877122 ↗
• InjuryFeb 10, 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

  MAUDE report 11308320 ↗
• InjuryJan 6, 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; Inflammation

  MAUDE report 11121941 ↗
• InjuryOct 8, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE. IMPLANT BECAME LOOSE.

  Patient problems: Failure of Implant

  MAUDE report 10649009 ↗
• InjuryAug 3, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS PER COMPLAINT (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANT DISPLAYED A FAILURE OF OSSEOINTEGRATION AND THE DENTAL IMPLANT WAS EXPLANTED. THERE WAS 1 PATIENT INVOLVED IN THIS EVENT.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 10356754 ↗
• InjuryAug 3, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS PER COMPLAINT (B)(4) AFTER A CLINICAL PROCEDURE A DENTAL IMPLANT DISPLAYED A FAILURE OF OSSEOINTEGRATION AND THE DENTAL IMPLANT WAS EXPLANTED. THERE WAS 1 PATIENT INVOLVED IN THIS EVENT.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 10356571 ↗
• 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 9283240 ↗
• InjurySep 11, 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; Osteopenia/ Osteoporosis; Pain

  MAUDE report 8989685 ↗

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 · Terminated
  ImplantDirect 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 · Terminated
  REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
• Z-2125-2017 · May 2, 2017 · Terminated
  Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
• Z-2320-2016 · Jul 5, 2016 · Terminated
  RePlant Angled Abutment Part Number 6050-52-60