GLOBAL FX 2128-01-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295088103), received between May 17, 2019 and Nov 17, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2023Break; Break

  IT WAS REPORTED THAT WHEN RECEIVED, VISUAL EXAM FOUND THE JIG WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158992 ↗
• MalfunctionJul 20, 2022Break; Break

  IT WAS REPORTED THAT THE TIGHTENING SCREW TIP ON POSITIONING JIG BROKE OFF. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066353 ↗
• MalfunctionSep 24, 2019Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  WELD HOLDING JIG ADJUSTING SCREW HAS CRACKED AND IS NO LONGER HOLDING ADJUSTING SCREW TO JIG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9111430 ↗
• MalfunctionSep 13, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  BOLT FOUND TO BE STUCK IN POST CLEANING INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9036834 ↗
• MalfunctionMay 17, 2019Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW CAME APART FROM WELDED BACK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619633 ↗