Legacy™3 Implant 854711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.7 x 11.5 Platform 4.5mmD · Class 2 · Implant
All models of Legacy3 Implant (75)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct Legacy 3 dental implant is a root-form implant placed in the jaw bone. Most of its 402 adverse event reports describe the implant failing to fuse with the bone, and some describe loss of that bond or implants placed in the wrong position. The reports list 394 injuries and no deaths, and no recalls name this device. Reports rose from 10 in the prior 12 months to 20 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 403
- Deaths reported
- 0
- Injuries reported
- 395
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 403 adverse event reports that list this exact device (DI 10841307102182), received between Jun 19, 2018 and Sep 11, 2026 — classified as 395 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (214 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate214
- Loss of Osseointegration67
- Osseointegration Problem34
- Positioning Problem31
- Positioning Failure28
- Fracture6
- Adverse Event Without Identified Device or Use Problem5
- Device Appears to Trigger Rejection3
Patient problems
- Failure of Implant367
- Osteopenia/ Osteoporosis92
- Unspecified Infection68
- No Consequences Or Impact To Patient64
- Inflammation55
- Pain51
- Inadequate Osseointegration24
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 25 most recent of 403 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50737029 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50010460 ↗InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25831363 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628321 ↗InjuryMay 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25074690 ↗MalfunctionApr 1, 2026Material Discolored
DEVICE DE-/DISCOLORATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24758989 ↗InjuryFeb 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24447363 ↗InjuryFeb 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24447318 ↗InjuryFeb 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24447191 ↗InjuryFeb 13, 2026Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24336925 ↗InjuryFeb 13, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24334282 ↗InjuryJan 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fibrosis; Granuloma; Inadequate Osseointegration; Unspecified Infection
MAUDE report 24029155 ↗InjuryDec 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23937373 ↗InjuryNov 6, 2025Difficult to Insert; Difficult to Insert
COMPONENT DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23483840 ↗InjuryNov 5, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474353 ↗InjuryNov 5, 2025Osseointegration Problem; Osseointegration Problem
OSSEOINTEGRATION PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474337 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474336 ↗InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23461251 ↗InjuryNov 4, 2025Positioning Failure; Positioning Failure
InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23449896 ↗InjuryOct 31, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23436769 ↗InjuryMar 18, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21637070 ↗InjuryMar 17, 2025Positioning Failure; Labelling, Instructions for Use or Training Problem; Positioning Failure; Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21626962 ↗InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21316354 ↗
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 · TerminatedImplant 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 · TerminatedLegacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
- Z-0364-2020 · Aug 9, 2019 · TerminatedImplant 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 · TerminatedImplantDirect 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 · TerminatedSwishTapered Implant Intended for use in support for fixed bridgework.
- Z-0185-2018 · Oct 10, 2017 · TerminatedImplantDirect 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 · TerminatedImplant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Z-1112-2017 · Dec 12, 2016 · TerminatedSwishTapered Implant
- Z-0961-2017 · Nov 28, 2016 · TerminatedGoDirect Screw-Retaining Top Part Numbers: 4500-61
- Z-1920-2018 · Nov 15, 2016 · TerminatedImplantDirect 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 · TerminatedThe 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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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