VARIAX 629383SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327082432), received between Jan 17, 2023 and Oct 10, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 10, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  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 23263770 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT COMPLAINS OF PAIN AND BONE FUSION FAILURE AND SCREW BACKOUT WERE FOUND. IT WAS DETERMINED THAT THERE WAS NO INFECTION, BUT THERE WAS A SUSPICION OF METAL ALLERGY."

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16189653 ↗