Legacy™2 Implant 824711Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Ø4.7 x 11.5 Platform 4.5mmD · Class 2 · Implant

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

Quick summary

This Implant Direct Legacy 2 dental implant is a screw-shaped post placed in the jawbone to hold a replacement tooth. Most of the 292 reports describe the implant not bonding with the bone, and some describe parts not connecting or staying in place during placement. The number of reports rose from 11 in the prior 12 months to 19 in the last 12 months. The reports include no deaths and 286 injuries. 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: 292
Deaths reported: 0
Injuries reported: 286
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 292 adverse event reports that list this exact device (DI 10841307101383), received between Jan 4, 2019 and Jun 8, 2026 — classified as 286 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (154 reports).

2 other recalls cover devices cleared under the same FDA submission (K192221); 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate154
Loss of Osseointegration39
Osseointegration Problem33
Positioning Failure28
Positioning Problem22
Separation Failure5
Difficult to Insert3
Adverse Event Without Identified Device or Use Problem2

Patient problems

Failure of Implant252
Osteopenia/ Osteoporosis54
Inflammation53
Unspecified Infection48
No Clinical Signs, Symptoms or Conditions30
Inadequate Osseointegration29
No Consequences Or Impact To Patient29
Pain29

Recent adverse event reports

The 25 most recent of 292 reports, in the reporter's own words as published by the FDA.

InjuryJun 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25431744 ↗
InjuryApr 27, 2026Positioning Failure
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003469 ↗
InjuryApr 20, 2026Separation Failure
COMPONENT DOES NOT DISENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926134 ↗
InjuryApr 14, 2026Difficult to Insert
COMPONENT DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877327 ↗
InjuryMar 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24724877 ↗
InjuryJan 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24214967 ↗
InjuryJan 23, 2026Difficult to Insert
COMPONENT DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164837 ↗
InjuryJan 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24013074 ↗
InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23783993 ↗
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23533213 ↗
InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23489755 ↗
InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483713 ↗
InjuryNov 6, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483639 ↗
InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474749 ↗
InjuryNov 5, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474639 ↗
InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474471 ↗
InjuryNov 4, 2025Osseointegration Problem; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461422 ↗
InjuryNov 4, 2025Migration; Migration
PART MIGRATES.
Patient problems: Abscess
MAUDE report 23461374 ↗
InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Bone Fracture(s)
MAUDE report 23461362 ↗
InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23436849 ↗
InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 23436819 ↗
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436524 ↗
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436358 ↗
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436355 ↗
InjuryOct 27, 2025Positioning Failure; Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23391454 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192221. One submission often covers many models, so check the product and lot details in each record.

Z-0198-2022 · Sep 23, 2021 · Open, Classified
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Z-0197-2022 · Sep 23, 2021 · Open, Classified
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Device details

UDI-DI	`10841307101383`
Brand	Legacy™2 Implant
Model	824711
Company	Implant Direct Sybron Manufacturing LLC
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K192221
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 17, 2024

Device type (GMDN): Dental implant system

A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Other Implant, Endosseous, Root-Form devices

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All Implant, Endosseous, Root-Form devices →

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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