ACUMED 3070-27013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10806378126048), received between Jun 11, 2026 and Jun 11, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 28, 2026Open, Classified

   Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

   Z-2532-2026 · Root cause: Device Design · FDA record ↗

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.

• InjuryJun 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE SURGEON TRIED USING 2.7 NL SCREW IN THE RADIUS WHILE USING DORSAL SPANNING PLATE. SCREW HEAD WITH 1-2 THREADS BROKE IN HALF, LEAVING MAJORITY OF SCREW BURIED IN BONE WITH HEAD HANDED TO BACK TABLE TO BE DISCARDED. THE PROCEDURE WAS COMPLETED WITH THE SUGEON CONTINUING ON WITH OTHER SCREW HOLES. THERE WAS NO REPORTED DELAY IN SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25480445 ↗