JOURNEY II XR 74014451Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556687406), received between Apr 13, 2020 and Aug 18, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K173331); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY. WHILE INSERTING THE BASE PLATE USING THE JOURNEY II XR TIBIAL BASE IMPLANT IMPACTOR, IT WAS FOUND THAT A PIECE OF THE PLASTIC WAS BROKEN. THIS PIECE WAS RETRIEVED SUCCESSFULLY. SURGERY WAS COMPLETED WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336617 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS REPORTED THAT THREE UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), THE TIBIAL SPACER BLOCK STANDARD ((B)(4)) THE JOURNEY II XR TIBIAL BASE IMPLANT IMPACTOR ((B)(4)) AND THE JOURNEY UNI TIBIAL TRAIL INSERT SIZE 3-4/ 9 MM ((B)(4)) WERE NOTICED CRACKED. THE SCREW DEPTH GAUGE ((B)(4)), META-TAN ANTI ROTATION BAR ((B)(4)), HUMERAL RULER ((B)(4)), TWO SCREW DRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) THE JOURNEY II TKA FEMORAL TRIAL LEFT SIZE 5 ((B)(4)) AND 3.5 MM LOCKING SCREW GUIDE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593502 ↗
• InjuryApr 13, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE DEVICE BROKE. BROKEN PIECE FELL INSIDE THE BODY, BUT IT WAS CONFIRMED THAT THE ALL PIECES WERE RETRIEVED FROM THE BODY.

  Patient problems: Injury

  MAUDE report 9955316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173331. One submission often covers many models, so check the product and lot details in each record.

• Z-1045-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi
• Z-1044-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi
• Z-1042-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi
• Z-1043-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi