ACUMED 3065-20016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10806378125478), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K251132); 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.

• MalfunctionMar 13, 2026Material Integrity Problem

  IT WAS REPORTED: BILATERAL DISTAL RADIUS FRACTURES THAT EXTEND INTO THE PROXIMAL RADIUS. PT. IS A RATHER LARGE MALE. WE USED A WIDE RIGHT PLATE WITH THE MEDIUM EXTENSION PLATE AND A STANDARD LONG LEFT PLATE WITH THE NEUTRAL EXTENSION. IN BOTH THE LEFT AND RIGHT, AS DR. (B)(6) WAS FINISHING IS PROXIMAL FIXATION, HE WAS FULLY SEATING HIS SCREWS AND THE SCREWS BROKE. THEY BROKE RIGHT AT THE NECK OF THE SCREW WHERE THE HEAD AND BODY MEET. HE DID NOT USE AN EXCESSIVE AMOUNT OF TORQUE AS HE WAS FULLY SEATING THESE SCREWS. I BELIEVE HE BROKE THE 2.7 X 16 IN THE RIGHT RADIUS AND 2.7 X 14 IN THE LEFT RADIUS BUT I'M NOT 100% ON THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599071 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K251132. One submission often covers many models, so check the product and lot details in each record.

• Z-2532-2026 · May 28, 2026 · Open, Classified
  Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 30