VariAx 40-20908Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540567475), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "SURGEON ADVISED HE WAS REMOVING ONE OF OUR VARIAX FIBULA PLATES THAT HE HAD IMPLANTED 5 YEARS PRIOR & AT THE PLATE BONE INTERFACE AS PER ATTACHED PHOTO THERE WAS "GROSS METALLOSIS" AND "PRETTY BAD BONE EROSION" PLATE AND SCREWS HAVE BEEN SUCCESSFULLY REMOVED & WILL BE RETURNED ONCE DECONTAMINATED. SWABS HAVE BEEN SENT TO LOCAL PATHOLOGY."

  Patient problems: Erosion; Foreign Body Reaction

  MAUDE report 22441504 ↗