Legacy™4 Implant 884216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307103349), received between Apr 30, 2018 and Apr 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Device Or Component Shipped” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  DOCTOR REPORTS RECEIVED THE WRONG PART. DR DRILLED OSTEOTOMY AND REALIZED IT WAS THE WRONG IMPLANT. DOCTOR REPORTS HAVING TO DRIVE TO ANOTHER OFFICE FOR ANOTHER IMPLANT AND COMPLETED THE PROCEDURE IN THE SAME VISIT. INTERNAL INVESTIGATION SHOWS THAT THIS WAS THE ONLY INSTANCE THAT THIS SPECIFIC PRODUCT COMBINATION WAS ORDERED WHERE THIS ERROR OCCURRED AND THE ISSUE HAS BEEN CORRECTED. THIS IS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474588 ↗

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,