simply RePlant® Implant 603516URecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307108276), received between Oct 28, 2018 and Apr 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  USABILITY - WRONG PART USED.

  Patient problems: Failure of Implant

  MAUDE report 21779031 ↗
• InjuryDec 6, 2024Material Deformation; Material Deformation

  PART/INTERFACE DEFORMED.

  Patient problems: Failure of Implant

  MAUDE report 20860960 ↗
• InjuryMar 2, 2022Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Granuloma; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 13657218 ↗
• InjuryMar 31, 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; Fibrosis; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 11595823 ↗
• InjuryOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER COMPLAINT (B)(4), A DENTAL IMPLANT WAS EXTRACTED DUE TO ADVANCED PERIODONTITIS FROM TRAUMA. THERE WAS OSTEOTOMY AT THE EXTRACTION SOCKET.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8011986 ↗

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