GLOBAL UNITE 2100-30-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295416074), received between May 24, 2019 and Oct 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2019Break; Break

  AFTER STERILIZATION THE DEFECT WAS NOTICED, COLOR RING OF PROXIMAL BODIES IS LOOSE AND PARTLY DETACHED AND COLOR IS DETACHED FROM THE BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9139683 ↗
• MalfunctionMay 24, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT THEY HAD SOME PAINT COMING OFF TWO SEPARATE TRIALS. HOSPITALS WOULD NOT LET THEM USE IN CASES AND NEED TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641322 ↗