NA 04.118.554Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982109187), received between Jun 12, 2025 and Jun 12, 2025 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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.

• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THE SURGEON NOTED THAT SOME METAL MATERIAL SHAVINGS CAME OUT WHEN HE INSERTED THE SCREWS INTRAOPERATIVELY. SURGERY DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193049 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes