simply Legacy™2 Implant 824716URecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10841307107484), received between Sep 10, 2019 and Apr 14, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Positioning Failure” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Positioning Failure; Osseointegration Problem

  LACK OF STABILITY DURING PLACEMENT.

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

  MAUDE report 24877980 ↗
• InjuryMar 13, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24599591 ↗
• InjuryDec 4, 2025Malposition of Device; Malposition of Device

  LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716381 ↗
• InjuryFeb 3, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

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

  MAUDE report 21298502 ↗
• InjuryMay 24, 2024Premature Separation; Premature Separation

  PART NOT RETAINED ON MATING PART (E.G.,

  Patient problems: Failure of Implant

  MAUDE report 19395670 ↗
• InjuryNov 29, 2023Positioning Failure; Positioning Failure

  LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 18226988 ↗
• InjuryMay 10, 2023Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 16900993 ↗
• InjuryFeb 1, 2023Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 16276448 ↗
• InjuryJan 10, 2023Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, OPENED WRONG IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 16128802 ↗
• InjurySep 8, 2021Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 12438132 ↗
• InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 8979669 ↗

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,