Legacy™4 Implant 885211Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307103448), received between Sep 10, 2019 and Mar 27, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), COMPONENTS COULD NOT BE SEPERATED.

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

  MAUDE report 9887534 ↗
• InjuryOct 3, 2019Positioning Problem; Positioning Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 9150614 ↗
• InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 8980045 ↗

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,