Radius Plate PROlock II 21035-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120047299258), received between Dec 11, 2019 and Dec 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 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.

• MalfunctionDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 2.4MM LOCKING SCREW WENT THROUGH A PLATE HOLE OF A DISTAL RADIUS PLATE.

  Patient problems: No Information

  MAUDE report 9450373 ↗

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,