Legacy™3 Implant 855208Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 8 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 has 177 adverse event reports, with no deaths and 174 injuries. The reports mostly describe the implant failing to fuse with the jawbone or lacking enough initial stability after placement, and several patients had low bone density. No recalls name this device.
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
- 177
- Deaths reported
- 0
- Injuries reported
- 174
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 10841307102229), received between Dec 6, 2018 and Aug 10, 2026 — classified as 174 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (95 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 Osseointegrate95
- Loss of Osseointegration32
- Positioning Failure24
- Osseointegration Problem14
- Positioning Problem8
- Material Deformation2
- Break1
- Device Appears to Trigger Rejection1
Patient problems
- Failure of Implant157
- Osteopenia/ Osteoporosis33
- Pain28
- Unspecified Infection26
- No Consequences Or Impact To Patient20
- No Clinical Signs, Symptoms or Conditions19
- Inflammation16
- Inadequate Osseointegration14
Recent adverse event reports
The 25 most recent of 177 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50199926 ↗InjuryJan 7, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23996705 ↗InjuryJan 7, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23996704 ↗InjuryJan 7, 2026Positioning Failure; Osseointegration Problem
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23996700 ↗InjuryJan 7, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23996685 ↗InjuryNov 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23548049 ↗InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483613 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462999 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436857 ↗InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21647836 ↗InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21647821 ↗InjuryMar 19, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647816 ↗InjuryFeb 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338333 ↗InjuryJan 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21073019 ↗InjuryDec 6, 2024Positioning Failure; Positioning Failure
InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20583400 ↗InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20583207 ↗InjuryOct 14, 2024Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20444261 ↗InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20240181 ↗InjuryAug 7, 2024Positioning Failure; Failure to Osseointegrate; Positioning Failure; Failure to Osseointegrate
PRIMARY STABILITY COULDN'T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19933525 ↗InjuryAug 7, 2024Positioning Failure; Failure to Osseointegrate; Positioning Failure; Failure to Osseointegrate
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931962 ↗InjuryAug 7, 2024Positioning Failure; Failure to Osseointegrate; Positioning Failure; Failure to Osseointegrate
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931948 ↗InjuryJun 28, 2024Positioning Failure; Positioning Failure
InjuryJun 27, 2024Positioning Failure; Positioning Failure
InjuryJun 25, 2024Positioning Failure; Positioning Failure
COMPL:PRIMARY STABILITY COULDN¿T BE ACHI.
Patient problems: Failure of Implant
MAUDE report 19609200 ↗
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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