Legacy™4 Implant 875213Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10841307103059), received between Dec 31, 2019 and May 6, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Failure to Osseointegrate

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107497 ↗
• InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268157 ↗
• InjurySep 9, 2024Separation Failure; Separation Failure

  COMPONENT DOES NOT DISENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173300 ↗
• InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate

  PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 20069002 ↗
• InjurySep 15, 2023Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 17758043 ↗
• InjuryJan 11, 2023Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 16136195 ↗
• InjuryAug 5, 2022Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Granuloma; Unspecified Infection

  MAUDE report 15173318 ↗
• InjuryDec 31, 2019Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), PATIENT EXPERINCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 9534347 ↗

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,