JOURNEY 74035213Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556157282), received between May 29, 2020 and Jun 9, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Crack” (7 reports).

3 other recalls cover devices cleared under the same FDA submission (K111711); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, WHILE RESETTING THE TRAY, IT WAS NOTICED THAT THE JRNY II BCS ART ISRT TRL SZ 1-2 11MM RT WAS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640431 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492057 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492032 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492026 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12491996 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP ((B)(4)) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD ((B)(4)), THE SCREWDRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT ((B)(4)), R3 0 DEG 32 MM TRIAL 48 MM ((B)(4)), THE HONEYCOMB ((B)(4)), THE BOX CHISEL ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT ((B)(4)), THE LAG SCREW 3.2 GUIDE PIN SLEEVE ((B)(4)), THE MEDIUM HEXDRIVER ((B)(4)), THE SUBTROC LAG SCREW DRIVER ((B)(4)), THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) TWO THIN OSTEO BLADE 8X3 ((B)(4)), THE THIN OSTEO BLADE 12X3 ((B)(4)) AND THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) WERE NOTICED CRACKED. THE NAIL PROX DROP ((B)(4)), THE META ANTERIOR DROP ((B)(4)), THE MI Z HANDLE ACET REAMER ((B)(4)) AND TWO THIN OSTEO BLADE 8X3 ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593355 ↗
• MalfunctionJun 25, 2020Crack; Crack

  IT WAS REPORTED THE DEFECTIVE DEVICE WAS FOUND DURING WAREHOUSE INSPECTION. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10194312 ↗
• MalfunctionJun 25, 2020Crack; Crack

  IT WAS REPORTED THE DEFECTIVE DEVICE WAS FOUND DURING WAREHOUSE INSPECTION. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10194303 ↗
• MalfunctionMay 29, 2020Crack; Crack

  IT WAS REPORTED THAT DURING INSPECTION OF A LOANER KIT IN WAREHOUSE THE PART WAS FOUND BROKEN/ MISSING/ DEFORMED. THE DEVICE WILL NOT BE RETURNED. THERE WAS NO HARM TO PATIENT, NO DELAY, AND THE BROKEN PIECE WAS NOT REMAIN. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102489 ↗
• MalfunctionMay 29, 2020Crack; Crack

  IT WAS REPORTED THAT DURING INSPECTION OF A LOANER KIT IN WAREHOUSE THE PART WAS FOUND BROKEN/ MISSING/ DEFORMED. THE DEVICE WILL NOT BE RETURNED. THERE WAS NO HARM TO PATIENT, NO DELAY, AND THE BROKEN PIECE WAS NOT REMAIN. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102299 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5