JOURNEY 74025674Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556422298), received between Nov 21, 2019 and Nov 21, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SYNCOPE AFTER SURGERY. HOSPITALIZATION WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9356586 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY AFTER SURGERY. HOSPITALIZATION WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9356583 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY AFTER SURGERY. HOSPITALIZATION WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9356557 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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