VariAx 656322Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327068719), received between Jul 12, 2019 and Feb 14, 2023 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "VARIAX2 ANGLE STABLE SCREW NO LONGER HELD WHEN REPLACING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371086 ↗
• MalfunctionOct 27, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "ANGULAR STABILITY IS FUNCTIONLESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10743955 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MIDFOOT OPEN REDUCTION + INTERNAL FIXATION + LISFRANC STABILISATION. METALOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9549198 ↗
• MalfunctionJul 12, 2019Difficult to Insert; Difficult to Insert; Defective Device

  CUSTOMER REPORTED THAT : "WHEN PERFORMING OSTEOSYNTHESIS OF THE LOWER END OF THE RIGHT RADIUS, THE LOCKED SCREW DIA 2.7 LG 22MM DID NOT LOCK INTO THE PLATE".

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8784460 ↗