Peri-Loc 71173538Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010519658), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 malfunction.

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

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 16, 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.

• 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 (CASE(B)(4)), THE TIBIAL SPACER BLOCK STANDARD (CASE-(B)(4)) THE JOURNEY II XR TIBIAL BASE IMPLANT IMPACTOR (CASE-(B)(4)) AND THE JOURNEY UNI TIBIAL TRAIL INSERT SIZE 3-4/ 9 MM (CASE-(B)(4)) WERE NOTICED CRACKED. THE SCREW DEPTH GAUGE (CASE-(B)(4)), META-TAN ANTI ROTATION BAR (CASE-(B)(4)), HUMERAL RULER (CASE-(B)(4)), TWO SCREW DRIVER RELEASE HANDLE (CASE-(B)(4)), THE JOURNEY DCF AP FEM CUT BLK 4 (CASE-(B)(4)) THE JOURNEY II TKA FEMORAL TRIAL LEFT SIZE 5 (CASE-(B)(4)) AND 3.5 MM LOCKING SCREW GUIDE (CASE-(B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593494 ↗