Fibula Plate 3.5mm 21225-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120047298305), received between Nov 7, 2024 and Nov 7, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K063672); 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.

• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 MONTH POST-OP THE PATIENT HAD SORT OF ALLERGIC REACTION/IMMUNE RESPONSE. SEVEN MONTHS POST-OP THE PLATE AND SCREWS WERE EXPLANTED AND IMAGES SHOW THAT NON-LOCKING SCREWS OF A DIFFERENT MANUFACTURER WERE USED IN CONJUNCTION WITH I.T.S. IMPLANTS.

  Patient problems: Local Reaction

  MAUDE report 20629306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063672. One submission often covers many models, so check the product and lot details in each record.

• Z-1601-2026 · Jan 23, 2026 · Open, Classified
  I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 2160