Legacy™3 Implant 855216Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10841307102267), received between Jul 26, 2018 and Nov 5, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  OSSEOINTEGRATION ISSUE OCCURING WITHIN 3.

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

  MAUDE report 23475034 ↗
• InjuryMar 22, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18965026 ↗
• InjuryFeb 23, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 16426630 ↗
• InjuryNov 14, 2022Failure 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 15787397 ↗
• InjuryFeb 9, 2022Loss 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 13498345 ↗
• InjurySep 21, 2021Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12506338 ↗
• InjuryMay 21, 2021Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FRACTURE OF BONE DURING IMPLANT INSERTION.

  Patient problems: Failure of Implant

  MAUDE report 11862526 ↗
• InjuryFeb 16, 2021Positioning Problem; Positioning Problem

  PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FLACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 11330866 ↗
• InjuryDec 18, 2019Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (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 9487330 ↗
• InjurySep 14, 2019Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), IT WAS OBSERVED THAT PATIENT EXPERIENCED LACK OF PRIMARY STABILITY OF IMPLANT.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 9057000 ↗
• InjurySep 13, 2019Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 9050860 ↗
• InjurySep 11, 2019Osseointegration Problem; Osseointegration Problem

  AS PER COMPLAINT (B)(4), A DENTAL IMPLANT HAD A PROBLEM WITH OSSEOINTEGRATION AND WAS REMOVED. BONE LOSS WAS REPORTED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 8996450 ↗
• MalfunctionJul 26, 2018Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Inaccurate Information; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Inaccurate Information

  PER COMPLAINT (B)(4), CAP IS INCORRECTLY LABELED AS PART #: 835216. THIS MALFUNCTION WAS FOUND INTERNALLY.

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

  MAUDE report 7723793 ↗

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