NA 74033655Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010671851), received between Jan 27, 2021 and Jun 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIV ISRT SPACER SZ 5-6 15MM SNAPPED IN HALF. IT IS UNKNOWN HOW THE SURGERY WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208221 ↗
• MalfunctionJun 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIV ISRT SPACER SZ 5-6 15MM BROKE WHEN SURGEON MADE TRIAL. ONE PIECE BROKE INSIDE PATIENT'S WOUND. THE BROKEN PART WAS REMOVE USING CLAMP. ALL PIECES WERE REMOVED AND ACCOUNTED. THE WOUND WAS CAREFULLY WASHED TO MAKE SURE ALL DEBRIS WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155555 ↗
• MalfunctionDec 3, 2021Crack; Crack

  IT WAS REPORTED THAT THESE INSERT TRIALS AND SPACERS ARE CRACKED: GII PS HI FLEX ISRT TR S5-6 11, UNIV ISRT SPACER SZ5-6 13M, UNIV ISRT SPACER SZ 5-6 15MM, GII CR DEEP FLX ISR TR S5-6 9, AND GII CR DEEP FLX ISR TR S5-6 11. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924828 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, IT WAS NOTICED THAT THE UNIV INSERT SPACER SIZE 5-6 15MM WAS BROKEN. THERE WAS NO SIGNIFICANT DELAY AND IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852679 ↗
• MalfunctionJan 27, 2021Crack; Crack

  IT WAS REPORTED THAT THE UNIV ISRT SPACER SZ 5-6 15MM IS CHIPPED AND CRACKED. INCIDENT OCCURRED DURING A STANDARD OFFICE EFIP INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11234615 ↗

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