Legacy™2 Implant 833213Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10841307101611), received between Oct 18, 2019 and Dec 3, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

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

  MAUDE report 23708886 ↗
• InjuryApr 25, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 19185202 ↗
• InjuryApr 25, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 19185191 ↗
• InjuryJul 26, 2023Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 17394834 ↗
• InjuryFeb 2, 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; Inflammation; Osteopenia/ Osteoporosis; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 16282233 ↗
• InjurySep 7, 2022Osseointegration Problem; Osseointegration Problem

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

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

  MAUDE report 15372193 ↗
• InjuryFeb 28, 2022Failure 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 13620320 ↗
• InjuryJun 17, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE

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

  MAUDE report 12015707 ↗
• InjuryMay 26, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 11884382 ↗
• InjuryFeb 18, 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; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 11342819 ↗
• InjuryNov 12, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 10828218 ↗
• InjuryJul 31, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4) A PATIENT'S DENTAL IMPLANT FAILED TO OSSEOINTEGRATE. PAIN AND SWELLING WERE REPORTED. THE IMPLANT WAS REMOVED.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 10353609 ↗
• InjuryNov 29, 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; Pain

  MAUDE report 9390931 ↗
• InjuryOct 18, 2019Loss of Osseointegration; Loss of Osseointegration

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

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

  MAUDE report 9207912 ↗

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,