Legacy™4 Implant 883210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307103196), received between Jul 2, 2018 and Apr 14, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Osseointegration Problem; Osseointegration Problem

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

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

  MAUDE report 16743018 ↗
• InjuryAug 3, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. THERE WAS NO PATIENT IMPACT NOTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 10359917 ↗
• InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9568172 ↗
• MalfunctionJul 2, 2018Device-Device Incompatibility; Device-Device Incompatibility

  PER THE COMPLAINT, AFTER INSERTING THE IMPLANT, THE DOCTOR WAS NOT ABLE TO REMOVE THE IMPRESSION COPING FROM THE IMPLANT DURING SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7656298 ↗

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,