simply Legacy™2 Implant 825713URecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10841307107576), received between Aug 28, 2019 and Jul 30, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Loss of Osseointegration

  Loss of osseointegration.

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

  MAUDE report 50091678 ↗
• InjuryNov 5, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IMPLANT/ABUTMENT PARTIALLY VISIBLE.

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

  MAUDE report 23474684 ↗
• InjuryNov 5, 2025Positioning Failure; Positioning Failure

  LACK OF PRIMARY STABILITY.

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

  MAUDE report 23474424 ↗
• InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Abscess; Inadequate Osseointegration

  MAUDE report 23474420 ↗
• InjuryFeb 26, 2025Positioning Failure; Positioning Failure

  LACK OF PRIMARY STABILITY

  Patient problems: Failure of Implant

  MAUDE report 21473330 ↗
• InjuryFeb 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  DEFLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298508 ↗
• InjuryNov 5, 2024Separation Failure; Separation Failure

  PART/INTERFACE DOES NOT DISENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615559 ↗
• InjuryJun 25, 2024Failure to Osseointegrate; Failure to Osseointegrate

  PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 19608873 ↗
• InjuryJun 11, 2024Loss of Osseointegration; Loss of Osseointegration

  FAILURE OF INTEGRATION.

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

  MAUDE report 19513339 ↗
• InjuryMay 16, 2023Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 16938142 ↗
• InjuryMar 3, 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; Unspecified Infection

  MAUDE report 16476111 ↗
• InjuryJan 28, 2023Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 16261398 ↗
• InjuryJan 16, 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 16174651 ↗
• InjuryDec 14, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Inflammation; Unspecified Infection

  MAUDE report 15976346 ↗
• InjuryNov 4, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Inflammation; Unspecified Infection

  MAUDE report 15731848 ↗
• InjuryAug 19, 2022Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 15258729 ↗
• InjuryDec 2, 2020Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 10934530 ↗
• MalfunctionOct 14, 2020Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE COMPONENTS COULD NOT BE SEPERATED.

  Patient problems: Failure of Implant

  MAUDE report 10678125 ↗
• InjuryAug 28, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 8943267 ↗

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,