Legacy™2 Implant 833208Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10841307101581), received between Sep 13, 2019 and Jul 30, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Failure to Osseointegrate

  Failure to osseointegrate.

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

  MAUDE report 50091684 ↗
• InjuryMay 11, 2026Positioning Failure

  PRIMARY STABILITY COULDN¿T BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144567 ↗
• InjuryMar 18, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 24630197 ↗
• InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

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

  MAUDE report 23483816 ↗
• InjuryNov 4, 2025Material Deformation; Material Deformation

  COMPONENT OR INTERFACE DEFORMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462887 ↗
• InjuryNov 16, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

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

  MAUDE report 20701602 ↗
• InjuryNov 1, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

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

  MAUDE report 20592847 ↗
• InjuryApr 9, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19074418 ↗
• InjuryMar 12, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18889552 ↗
• InjuryApr 3, 2023Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Granuloma; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 16665723 ↗
• InjuryApr 3, 2023Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Granuloma; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 16665713 ↗
• InjuryNov 28, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant

  MAUDE report 15874927 ↗
• InjuryNov 28, 2022Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(6), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 15874789 ↗
• InjurySep 23, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 15470038 ↗
• InjuryApr 9, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 11641441 ↗
• InjuryDec 20, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 9501775 ↗
• InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE DUE TO OSSEOINTEGRATION.

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

  MAUDE report 9050816 ↗

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,