Legacy™2 Implant 825716Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307101529), received between Oct 11, 2019 and Mar 13, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Pain; Unspecified Infection

  MAUDE report 21600617 ↗
• InjuryOct 13, 2021Failure 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 12624146 ↗
• InjuryMar 30, 2021Positioning Problem; Positioning Problem

  PER (B)(4), THE DENTAL IMPLANT DID NOT HAVE PRIMARY STABILITY. PATIENT EXPERIENCED INFLAMMATION AND FIBROUS TISSUE.

  Patient problems: Failure of Implant; Fibrosis; Inflammation

  MAUDE report 11592859 ↗
• InjuryJun 24, 2020Positioning Problem; Positioning Problem

  PER (B)(4), THE DENTAL IMPLANT DID NOT HAVE PRIMARY STABILITY. PATIENT EXPERIENCED A BONE FRACTURE.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 10192490 ↗
• InjuryOct 11, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED CHRONIC INFECTION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9178094 ↗

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,