NA 394.797Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982199829), received between Oct 31, 2025 and Oct 31, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K122455); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ITEMS NEED REPLACING, THE DRILL SLEEVES CATCH. THERE IS WHITE RESIDE ON THE BARS AND CHIPS ON THE BARS, 4.0 ADAPTERS DO NOT WORK. THERE WERE NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442065 ↗
• MalfunctionOct 31, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ITEMS NEED REPLACING, THE DRILL SLEEVES CATCH. THERE IS WHITE RESIDE ON THE BARS AND CHIPS ON THE BARS, 4.0 ADAPTERS DO NOT WORK. THERE WERE NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122455. One submission often covers many models, so check the product and lot details in each record.

• Z-2451-2015 · Jul 29, 2015 · Terminated
  Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as th
• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.