Legacy™2 Implant 825210Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 10 Platform 4.5mmD · Class 2 · Implant
All models of Legacy2 Implant (78)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Legacy 2 implant from Implant Direct is a screw placed in the jawbone to support a replacement tooth. Of its 277 reports, 267 are injury reports and 10 are malfunction reports, with no deaths. They mostly describe the implant failing to bond with the bone, some implants later losing that bond, and infection or inflammation reported around the implant. 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
- 279
- Deaths reported
- 0
- Injuries reported
- 269
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 10841307101437), received between Aug 6, 2018 and Sep 29, 2026 — classified as 269 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (143 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
Most reported problems
Device problems
- Failure to Osseointegrate143
- Positioning Failure36
- Osseointegration Problem24
- Positioning Problem24
- Loss of Osseointegration20
- Adverse Event Without Identified Device or Use Problem6
- Fracture4
- Premature Separation4
Patient problems
- Failure of Implant225
- Inflammation47
- Inadequate Osseointegration36
- No Clinical Signs, Symptoms or Conditions36
- No Consequences Or Impact To Patient34
- Unspecified Infection33
- Osteopenia/ Osteoporosis29
- Pain21
Recent adverse event reports
The 25 most recent of 279 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934830 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780401 ↗InjuryApr 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24900134 ↗InjuryApr 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 24866359 ↗InjuryApr 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 24818540 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793666 ↗InjuryMar 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24670639 ↗InjuryMar 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24558438 ↗InjuryFeb 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24326744 ↗InjuryFeb 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24240557 ↗InjuryJan 23, 2026Use of Device Problem
COMPONENT OR INTERFACE DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24166840 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679917 ↗InjuryNov 29, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23676854 ↗InjuryNov 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23640655 ↗InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2025Positioning Failure; Positioning Failure
InjuryNov 6, 2025Malposition of Device; Malposition of Device
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23483764 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483710 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483683 ↗InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 23483635 ↗InjuryNov 5, 2025Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474432 ↗InjuryNov 5, 2025Migration; Migration
PART MIGRATES.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474230 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 23462830 ↗InjuryNov 4, 2025Separation Failure; Separation Failure
PART/INTERFACE DOES NOT DISENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462794 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461501 ↗
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, ClassifiedImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- Z-0197-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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