ACUMED 3070-27014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10806378126055), received between Jan 27, 2026 and May 6, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Material Fragmentation

  IT WAS REPORTED: 2 2.7MM NL SCREWS FROM AL NEXT BROKE DURING THE CASE. THE FIRST SCREW (16MM) BROKE WHILE THE SCREW WAS BEING USED TO PULL THE PLATE TO THE BONE. THE HEAD OF THE SCREW BROKE IN HALF AND THEN FELL THROUGH THE SLOT IN THE PLATE. THE SECOND SCREW HEAD SNAPPED OFF THE SCREW BEFORE IT WAS EVEN DOWN TO THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104609 ↗
• 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. YARI 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 24594392 ↗
• InjuryJan 27, 2026Break

  IT WAS REPORTED THAT A 2.7 X 14 MM NON-LOCKING SCREW WAS PLACED INTO THE OBLONG HOLE OF THE DISTAL RADIUS PLATE. WHILE TAKING FINAL X RAYS WE NOTICED THAT THE SCREW WAS TOO LONG AND NEEDED TO BE REPLACED. WHEN THE RESIDENT WENT TO REMOVE THE SCREW, THE HEAD OF THE SCREW SNAPPED OFF. THE SCREW WAS LEFT IN THE BONE, AND THE SCREW WAS CUT FROM THE DORSAL END SO IT WAS FLUSH WITH BONE. THERE WERE 30 MINUTE DELAY AND ADDITIONAL INCISION REQUIRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24195770 ↗