TRIGEN 71631434Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556158388), received between Mar 19, 2021 and Mar 30, 2021 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K122170); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 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 ((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 11593501 ↗
• MalfunctionMar 19, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, THE HANDLE OF A META-TAN ANTI ROTATION BAR IS OUT OF ALIGNMENT. INCIDENT OCCURRED DURING A META TAN NAILING CASE WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11522611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha