Legacy™3 Implant 864713Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10841307102595), received between Feb 19, 2018 and Sep 30, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

Recent adverse event reports

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

• InjurySep 30, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20337425 ↗
• InjuryJan 19, 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; Granuloma; Osteopenia/ Osteoporosis

  MAUDE report 16202505 ↗
• InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Granuloma; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 13564697 ↗
• InjuryNov 15, 2021Loss of Osseointegration; Loss of Osseointegration

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

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

  MAUDE report 12810857 ↗
• InjuryDec 17, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 11025876 ↗
• InjuryNov 25, 2020Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 10904200 ↗
• InjurySep 19, 2020Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant

  MAUDE report 10557727 ↗
• InjuryAug 27, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. PATIENT EXPERIENCED INFECTION AND INFLAMMATION.

  Patient problems: Failure of Implant; Inflammation; Unspecified Infection

  MAUDE report 10462865 ↗
• InjuryFeb 25, 2020Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9749003 ↗
• InjuryOct 11, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Unspecified Infection; Wound Dehiscence

  MAUDE report 9178112 ↗
• InjurySep 12, 2019Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT FELT THE IMPLANT WAS LOOSE AND DURING THE POST OPERATIVE CHECK THE ABUTMENT HEX SHEARED OFF FROM THE IMPLANT ABUTMENT.

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

  MAUDE report 9003448 ↗
• InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 8989595 ↗
• InjuryFeb 19, 2018Device Issue; Device Issue

  MDR SUBMISSION FOR HHE (B)(4) PRODUCT COMPLAINT# (B)(4) REPORTS PATIENT PRESENTED WITH PARESTHESIA OF THREE WEEKS DURATION. RADIOGRAPHS ALTHOUGH HARD TO READ COULD BE INTERPRETED AS IMPLANTS #29 AND #31 IMPINGING ON MANDIBULAR NERVE. DECISION TO BACK THESE TWO IMPLANTS. REPLACED #31 WITH 11.5 MML AND #29 WITH 13MML. ALLOWING #29 IMPLANT SITE TO HEAL FOUR MONTHS BEFORE REPLACING FIXTURE. NO INFECTION AND OSSEOINTEGRATION APPEARED TO BE PROCEEDING WELL.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7281407 ↗
• InjuryFeb 19, 2018Device Issue; Device Issue

  MDR SUBMISSION FOR (B)(4) REPORTS PATIENT PRESENTED WITH PARESTHESIA OF THREE WEEKS DURATION. RADIOGRAPHS ALTHOUGH HARD TO READ COULD BE INTERPRETED AS IMPLANTS #29 AND #31 IMPINGING ON MANDIBULAR NERVE. DECISION TO BACK THESE TWO IMPLANTS. REPLACED #31 WITH 11.5 MML AND #29 WITH 13MML. ALLOWING #29 IMPLANT SITE TO HEAL FOUR MONTHS BEFORE REPLACING FIXTURE. NO INFECTION AND OSSEOINTEGRATION APPEARED TO BE PROCEEDING WELL.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7281364 ↗

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