Legacy™2 Implant 833211Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10841307101604), received between Feb 27, 2019 and Apr 27, 2026 — classified as 14 injuries, 1 malfunction.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

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

  MAUDE report 25000575 ↗
• InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 23436811 ↗
• InjuryMar 24, 2025Fracture; Fracture

  PART FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684079 ↗
• InjuryOct 3, 2024Failure to Osseointegrate; Failure to Osseointegrate

  PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 20361714 ↗
• InjuryOct 5, 2023Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 17875474 ↗
• InjuryJul 6, 2023Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 17271330 ↗
• InjuryJun 24, 2023Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant

  MAUDE report 17195931 ↗
• InjuryApr 26, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 11724147 ↗
• InjuryMar 23, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 11552266 ↗
• 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; Granuloma; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 11341362 ↗
• InjuryJan 29, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 11250618 ↗
• InjuryJul 30, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), IMPLANT HAD FAIL INTEGRATION. PATIENT EXPERIENCED BONE LOSS AND FIBROUS TISSUE.

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

  MAUDE report 10348176 ↗
• InjuryDec 27, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Inflammation; Pain

  MAUDE report 9522897 ↗
• InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4). DURING POST OPERATIVE CHECK IT WAS OBSERVED THAT PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE. BONE LOSS WAS ALSO OBSERVED AND BONE GRAFT WAS PLACED.

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

  MAUDE report 9025310 ↗
• MalfunctionFeb 27, 2019Fracture; Fracture

  PER COMPLAINT (B)(4), A COVER SCREW FRACTURED WITHIN THE HEAD OF A PATIENT'S DENTAL IMPLANT DURING INITIAL PLACEMENT. THE IMPLANT WAS REMOVED ALONG WITH THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITHIN THE SAME VISIT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 8375587 ↗

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-0197-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
• Z-0198-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,