Legacy™4 Implant 884208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307103301), received between Nov 13, 2019 and Feb 23, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 11366139 ↗
• InjuryFeb 12, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 11321429 ↗
• InjuryJul 8, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. PATIENT DID NOT EXPERIENCE ANY IMPACT.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 10248459 ↗
• InjuryNov 13, 2019Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BUCCAL BONE FRACTURE WAS OBSERVED.

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

  MAUDE report 9313689 ↗

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