RePlant® Implant 606013Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841307104162), received between Sep 9, 2019 and Nov 22, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Malposition of Device; Malposition of Device

  LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763515 ↗
• InjuryNov 29, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY COULDN¿T BE ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 18223711 ↗
• InjuryJan 7, 2022Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 13191978 ↗
• InjurySep 24, 2020Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant

  MAUDE report 10580139 ↗
• InjuryJan 14, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9585523 ↗
• InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), PATIENT REPORTED TO DOCTOR MANY TIMES WITH PAIN,INFECTION & SWELLING AND LATER IMPLANT WERE REMOVED.

  Patient problems: Failure of Implant; Impaired Healing; Inflammation; Pain; Unspecified Infection

  MAUDE report 8976457 ↗

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