Legacy™3 Implant 853711Recalls & reported problems

Summary

The FDA's MAUDE database contains 758 adverse event reports that list this exact device (DI 10841307102069), received between Mar 8, 2018 and Jul 17, 2026 — classified as 748 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (444 reports).

11 other recalls cover devices cleared under the same FDA submission (K090234); 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 25 most recent of 758 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25863881 ↗
• InjuryJul 17, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25862806 ↗
• InjuryJul 17, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25860845 ↗
• InjuryJun 26, 2026Positioning Failure; Osseointegration Problem

  PRIMARY STABILITY COULDN¿T BE ACHI.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644198 ↗
• InjuryJun 9, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25446490 ↗
• InjuryJun 9, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25446320 ↗
• InjuryJun 9, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25446106 ↗
• InjuryJun 9, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25445789 ↗
• InjuryJun 9, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25445714 ↗
• InjuryJun 8, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; Inflammation

  MAUDE report 25428661 ↗
• InjuryJun 6, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419652 ↗
• InjuryMay 11, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25135571 ↗
• InjuryMay 4, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072047 ↗
• InjuryApr 23, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967123 ↗
• InjuryApr 6, 2026Positioning Failure

  LACK OF STABILITY DURING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791554 ↗
• InjuryMar 11, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Inflammation

  MAUDE report 24570401 ↗
• InjuryFeb 26, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464755 ↗
• InjuryFeb 9, 2026Failure to Osseointegrate

  LACK OF STABILITY DURING PLACEMENT.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291465 ↗
• InjuryJan 9, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Granuloma; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 24029154 ↗
• InjuryDec 30, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem

  LACK OF STABILITY DURING PLACEMENT.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928105 ↗
• InjuryDec 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23797911 ↗
• InjuryDec 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IMPLANT/ABUTMENT PARTIALLY VISIBLE

  Patient problems: Abscess; Inadequate Osseointegration

  MAUDE report 23785575 ↗
• InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783981 ↗
• InjuryDec 9, 2025Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763033 ↗
• InjuryNov 13, 2025Malposition of Device; Malposition of Device

  LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547520 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090234. One submission often covers many models, so check the product and lot details in each record.

• Z-1157-2020 · Oct 11, 2019 · Terminated
  Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
• Z-1041-2020 · Oct 7, 2019 · Terminated
  Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
• Z-0364-2020 · Aug 9, 2019 · Terminated
  Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
• Z-0018-2020 · Aug 8, 2018 · Terminated
  ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The re
• Z-1167-2018 · Jan 19, 2018 · Terminated
  SwishTapered Implant Intended for use in support for fixed bridgework.
• Z-0185-2018 · Oct 10, 2017 · Terminated
  ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for
• Z-0007-2018 · Jul 21, 2017 · Terminated
  Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
• Z-1112-2017 · Dec 12, 2016 · Terminated
  SwishTapered Implant
• Z-0961-2017 · Nov 28, 2016 · Terminated
  GoDirect Screw-Retaining Top Part Numbers: 4500-61
• Z-1920-2018 · Nov 15, 2016 · Terminated
  ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
• Z-1267-2016 · Mar 4, 2016 · Terminated
  The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Numbe