Legacy™2 Implant 835213Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307101857), received between Jan 15, 2019 and Feb 28, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 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; Osteopenia/ Osteoporosis; Pain

  MAUDE report 16453733 ↗
• InjuryFeb 3, 2022Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Granuloma

  MAUDE report 13441435 ↗
• MalfunctionJan 15, 2019Material Deformation; Scratched Material; Material Deformation; Scratched Material

  PER COMPLAINT (B)(4), THE INTERNAL HEX OF A DENTAL IMPLANT WAS STRIPPED DURING INITIAL PLACEMENT. THE IMPLANT WAS REMOVED AND 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 8248380 ↗

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,