LEGION 71425205Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556108574), received between Jun 3, 2026 and Jun 3, 2026 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K091543, K230653); 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.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED WITH LEGION SYSTEM ON (B)(6) 2014, THE CLINICAL SUBJECT EXPERIENCE LEFT KNEE PAIN. THIS ADVERSE EVENT WAS TREATED BY SURGERY ON (B)(6) 2020. THE ADVERSE EVENT WAS RESOLVED.

  Patient problems: Arthralgia

  MAUDE report 25369344 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091543, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint