Cortical Stabilization Screw 37304-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120047295113), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K033756); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LOCKING SCREWS DIDN'T LOCK IN A RADIUS PLATE 3-HOLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15915712 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033756. One submission often covers many models, so check the product and lot details in each record.

• Z-1592-2026 · Jan 23, 2026 · Open, Classified
  Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5,