LEGION 71425208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556108543), received between Apr 21, 2023 and Nov 16, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2023, PATIENT WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS OF IN ONE OF GASTROCNEMIUS AND POPLITEAL VEINS. THIS ADVERSE EVENT WAS ADDRESSED BY GIVING PATIENT MEDICATION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23565747 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA WAS PERFORMED ON 07-JAN-18, THE PATIENT EXPERIENCED ARTHROFIBROSIS. THIS EVENT WAS TREATED BY PERFORMING AN ADDITIONAL SURGERY ON (B)(6) 2023. PATIENT'S OUTCOME IS ONGOING.

  Patient problems: Fibrosis; Loss of Range of Motion; Pain

  MAUDE report 16788522 ↗

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