JOURNEY 74035212Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556157237), received between Jul 24, 2020 and Mar 4, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 1-2 10MM RT WAS FOUND CRACKED AND SCRATCHED. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666662 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT ((B)(4)), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT ((B)(4)), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM ((B)(4)), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM ((B)(4)),JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM ((B)(4)), THREE HONEYCOMB ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT ((B)(4)) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(4)) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER ((B)(4)) AND SCREWDRIVER RELEASE HANDLE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593414 ↗
• MalfunctionDec 21, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050868 ↗
• MalfunctionDec 21, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICE WAS FOUND CRACKED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050623 ↗
• MalfunctionJul 24, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE JOURNEY II BCS ARTICULAR INSERT WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

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

  MAUDE report 10318375 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS ARTICULAR INSERT WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10318372 ↗

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