JOURNEY 74029262Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556176467), received between Oct 1, 2018 and Oct 1, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K140555, 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.

Recalls naming this device

1. Sep 27, 2023Class IIOpen, Classified

   The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

   Z-0158-2024 · Root cause: Component change control · Recall details · FDA record ↗

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.

• InjuryOct 1, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FEELINGS OF INSTABILITY AND EFFUSIONS. DOCTOR PLANNED TO EXAMINE THE PATIENT UNDER ANESTHESIA AND REVISE THE JOINT TO GIVE MORE STABILITY.

  Patient problems: Injury

  MAUDE report 7922094 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• 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