JOURNEY 74025763Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556098516), received between Oct 27, 2023 and Oct 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113482, 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.

• MalfunctionOct 27, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN OPENING THE BOX OF THE JRNY II ISRT XLPE DD LT SZ 5-6 11MM DEVICE, IT WAS FOUND THAT THE DOUBLE STERILE PACKAGES WERE OPEN ON SAME SITE. THERE WAS NO DAMAGE ON THE BOX. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021342 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113482, 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