VARIAX 657330SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327087086), received between Apr 5, 2022 and Oct 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "ATTEMPTED TO PUT A LOCKING SCREW IN THE MOST DISTAL HOLE OF THE 3 HOLES OF THE INNER PLATE OF THE VARIAX ELBOW, BUT IT DID NOT LOCK. TRIED A DIFFERENT SIZE BUT DID NOT LOCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263789 ↗
• MalfunctionDec 22, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "THREADED PIECES OF METAL APPEARED WHEN TIGHTENING A SCREW TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387320 ↗
• MalfunctionDec 22, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "THREADED PIECES OF METAL APPEARED WHEN TIGHTENING A SCREW TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387230 ↗
• MalfunctionApr 5, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING FAILURE OCCURRED. SPARE SCREW WAS USED AND THE SURGERY WAS FINISHED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14012517 ↗