JOURNEY II XR 74013991Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556696064), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 injury.

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

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

• InjuryAug 10, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN USING A JII XR POSTERIOR KEEL PUNCH TIB SZ 3-4 (B)(4) AND A JII XR TIBIA SZ 3-8 ANTERIOR KEEL PUNCH (B)(4) A VERTICAL FRACTURE OF 2-3 MM NON DISPLACED WAS OBSERVED IN THE TIBIA. THE SURGERY WAS COMPLETED AS PLANNED WITH THE IMPLANTATION AND THE XR TIBIA BASEPLATE AND NO FURTHER ACTION WAS TAKEN TO TREAT THE CRACK. IT IS UNKNOWN IF THERE WAS ANY DELAY OR THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304110 ↗

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-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
• 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-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