simply RePlant® Implant 605016URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307108375), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2020Positioning Problem; Positioning Problem

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

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

  MAUDE report 10380090 ↗

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