VARIAX 657355SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327087413), received between Feb 10, 2023 and Oct 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 2 most recent of 2 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 23263780 ↗
• MalfunctionFeb 10, 2023Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: METAL FRAGMENTS WERE OBSERVED WHEN A NON-LOCKING SCREW WAS INSERTED IN THE OVAL HOLE AND A LOCKING SCREW IN THE ROUND HOLE, RESPECTIVELY. ONLY THE METAL FRAGMENTS WERE RETRIEVED. THE LOCKING SCREW DID NOT LOCK UPON INSERTION AND WAS SPINNING ALL THE TIME.

  Patient problems: Insufficient Information

  MAUDE report 16353077 ↗