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Legacy™3 Implant 863708Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · 3.7mmD x 8mmL, 3.5mmD Platform · Class 2 · Implant

All models of Legacy3 Implant (75)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
14
Deaths reported
0
Injuries reported
14
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10841307102441), received between May 10, 2018 and Sep 30, 2022 — classified as 14 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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

Device problems

  • Failure to Osseointegrate8
  • Loss of Osseointegration3
  • Biocompatibility2
  • Osseointegration Problem1

Patient problems

  • Failure of Implant14
  • No Consequences Or Impact To Patient5
  • Osteopenia/ Osteoporosis4
  • Irritation2
  • No Code Available2
  • Inflammation1
  • No Information1
  • Unspecified Infection1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2022Loss of Osseointegration; Loss of Osseointegration

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

    Patient problems: Failure of Implant

    MAUDE report 15519959 ↗
  • InjuryOct 14, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant

    MAUDE report 10676120 ↗
  • InjuryApr 17, 2020Loss of Osseointegration; Loss of Osseointegration

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

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

    MAUDE report 9971680 ↗
  • InjuryApr 16, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

    MAUDE report 9966689 ↗
  • InjuryMar 17, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

    MAUDE report 9840841 ↗
  • InjuryMar 17, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

    MAUDE report 9840778 ↗
  • InjuryNov 29, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

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

    MAUDE report 9390893 ↗
  • InjuryNov 12, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

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

    MAUDE report 9309039 ↗
  • InjurySep 23, 2019Loss of Osseointegration; Loss of Osseointegration

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

    Patient problems: Failure of Implant; No Information

    MAUDE report 9103435 ↗
  • InjurySep 12, 2019Osseointegration Problem; Osseointegration Problem

    PER COMPLAINT (B)(4), THE IMPLANT WAS EXTRACTED DUE TO IMPLANT FLUCTUATION 1 YEAR AFTER PROSTHETIC.

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

    MAUDE report 9003563 ↗
  • InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, LOOSENING OF FIXTURE WAS OBSERVED. PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

    Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

    MAUDE report 8989662 ↗
  • InjurySep 5, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

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

    MAUDE report 8963667 ↗
  • InjuryMay 10, 2018Biocompatibility; Biocompatibility

    ACCORDING TO THE COMPLAINT, AN IMPLANT FAILED AND PATIENT HAD AN ALLERGY TO THE IMPLANT. THIS IS A REPORTABLE SERIOUS INJURY.

    Patient problems: Failure of Implant; Irritation; No Code Available

    MAUDE report 7504695 ↗
  • InjuryMay 10, 2018Biocompatibility; Biocompatibility

    ACCORDING TO THE COMPLAINT, AN IMPLANT FAILED AND PATIENT HAD AN ALLERGY TO THE IMPLANT. THIS IS A REPORTABLE SERIOUS INJURY.

    Patient problems: Failure of Implant; Irritation; No Code Available

    MAUDE report 7504626 ↗

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

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Sources and updates

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