Cancellous Screw, Cannulated 31404-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120034306099), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K060156); 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.

• MalfunctionMar 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A CANNULATED SCREW 4.0MM L=60MM COULDN'T BE SLIDED OVER THE GUIDE WIRE DURING THE IMPLANTATION. A SECOND CANNULATED SCREW 4.0MM L=60MM FROM THE TRAY WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476712 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060156. One submission often covers many models, so check the product and lot details in each record.

• Z-1599-2026 · Jan 23, 2026 · Open, Classified
  I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404
• Z-1598-2026 · Jan 23, 2026 · Open, Classified
  I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Fore