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JOURNEY 74035833Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II UK RESECTION PREPARATION TRIAL RIGHT MEDIAL/LEFT LATERAL SIZE 3 · Class 2

All models of JOURNEY (566)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556690444), received between Nov 20, 2020 and Nov 20, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K190085); 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

Device problems

  • Connection Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 20, 2020Connection Problem; Connection Problem

    IT WAS REPORTED THAT THE SLIDING MECHANISM FELL OUT OF THE JRNY II UNI RESECT PREP TRL RM/LL SZ 3. IT IS UNKNOWN WHEN THE INCIDENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS ANY CASE INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10879672 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190085. One submission often covers many models, so check the product and lot details in each record.

  • Z-1393-2023 · Mar 27, 2023 · Open, Classified
    JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
  • Z-2133-2020 · Jan 28, 2020 · Terminated
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti
  • Z-2132-2020 · Jan 28, 2020 · Terminated
    JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page