RePlant® Implant 606011Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10841307104155), received between Mar 8, 2018 and Nov 29, 2023 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY COULDN¿T BE ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 18223709 ↗
• InjuryJul 31, 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; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 17425231 ↗
• InjuryJun 13, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant

  MAUDE report 14675227 ↗
• InjuryFeb 25, 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; Unspecified Infection

  MAUDE report 13599016 ↗
• InjurySep 16, 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; Insufficient Information

  MAUDE report 12480596 ↗
• InjuryJul 8, 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; Osteopenia/ Osteoporosis

  MAUDE report 12134737 ↗
• InjuryMar 16, 2021Loss of Osseointegration; Loss of Osseointegration

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

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

  MAUDE report 11495354 ↗
• InjuryAug 12, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 10398577 ↗
• InjuryFeb 26, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS PER COMPLAINT (B)(4), DURING A CLINICAL PROCEDURE, A PATIENT PRESENTED A DENTAL IMPLANT THAT DISPLAYED AN OSSEOINTEGRATION PROBLEM AND THE IMPLANT WAS EXPLANTED. NO PATIENT IMPACT WAS RECORDED.

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

  MAUDE report 9757647 ↗
• InjuryFeb 7, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 9680241 ↗
• MalfunctionMar 8, 2018Device-Device Incompatibility; Device-Device Incompatibility

  PER (B)(4) COMPLAINANT REPORTED ONCE IMPLANT PLACED COULD NOT UNSCREW CARRIER OFF. LOT NUMBER UNKNOWN AS NOT REPORTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7324356 ↗

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