VariAx 656318SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327070705), received between Dec 2, 2020 and Feb 2, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Positioning Failure

  AS REPORTED: "SCREWS DID NOT LOCK ONTO THE PLATE. THE PROCEDURE WAS COMPLETED USING SCREWS OF THE SAME PART NUMBER BUT FROM A DIFFERENT LOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235224 ↗
• MalfunctionOct 16, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "THE SCREW DID NOT LOCK PROPERLY AT THE SECOND HOLE FROM THE DISTAL END OF THE PLATE ON THE ULNAR SIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317545 ↗
• InjurySep 4, 2024Biocompatibility; Biocompatibility

  THE FOLLOWING EMAIL WAS RECEIVED FROM A PATIENT: "I HAD SURGERY FOR A BROKEN WRIST ON (B)(6) LAST YEAR. I HAD AN ALLERGIC REACTION TO IT AND WOULD NOW LIKE TO HAVE IT TESTED TO FIND OUT EXACTLY WHAT I AM ALLERGIC TO. THE DERMATOLOGIST ASKED ME TO REQUEST AN 'INGREDIENT LIST' SO THAT THEY COULD KNOW WHICH SAMPLES TO USE FOR TESTING. THE ALLERGY WAS DISCOVERED ON (B)(6) 2023. THE PLATE AND SCREWS WERE REMOVED."

  Patient problems: Foreign Body Reaction

  MAUDE report 20140749 ↗
• InjurySep 4, 2024Biocompatibility; Biocompatibility

  THE FOLLOWING EMAIL WAS RECEIVED FROM A PATIENT: "I HAD SURGERY FOR A BROKEN WRIST ON (B)(6) LAST YEAR. I HAD AN ALLERGIC REACTION TO IT AND WOULD NOW LIKE TO HAVE IT TESTED TO FIND OUT EXACTLY WHAT I AM ALLERGIC TO. THE DERMATOLOGIST ASKED ME TO REQUEST AN 'INGREDIENT LIST' SO THAT THEY COULD KNOW WHICH SAMPLES TO USE FOR TESTING. THE ALLERGY WAS DISCOVERED ON (B)(6) 2023 THE PLATE AND SCREWS WERE REMOVED."

  Patient problems: Foreign Body Reaction

  MAUDE report 20140743 ↗
• InjurySep 4, 2024Biocompatibility; Biocompatibility

  THE FOLLOWING EMAIL WAS RECEIVED FROM A PATIENT: "I HAD SURGERY FOR A BROKEN WRIST ON (B)(6) 2022 LAST YEAR. I HAD AN ALLERGIC REACTION TO IT AND WOULD NOW LIKE TO HAVE IT TESTED TO FIND OUT EXACTLY WHAT I AM ALLERGIC TO. THE DERMATOLOGIST ASKED ME TO REQUEST AN 'INGREDIENT LIST' SO THAT THEY COULD KNOW WHICH SAMPLES TO USE FOR TESTING. THE ALLERGY WAS DISCOVERED ON (B)(6) 2023. THE PLATE AND SCREWS WERE REMOVED."

  Patient problems: Foreign Body Reaction

  MAUDE report 20140742 ↗
• MalfunctionJan 5, 2024Contamination /Decontamination Problem; Difficult to Open or Remove Packaging Material; Contamination /Decontamination Problem; Difficult to Open or Remove Packaging Material

  AS REPORTED: "DURING THE INTRAOPERATIVE OPENING OF THE IMPLANT, THE OUTER PACKAGING DID NOT COME OFF SMOOTHLY AND THE INNER CASE WAS DROPPED, MAKING IT UNCLEAN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454732 ↗
• MalfunctionSep 5, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "SCREW HAS GOT A BURR. THIS WAS NOTICED WHEN UNPACKING THE STERILE PACKAGING. THEY USED A DIFFERENT SCREW TO FINISH THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687100 ↗
• MalfunctionJan 30, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN LOCKING THE SCREW TO THE PLATE, ONCE IT WAS LOCKED, IT SPUN OUT WHEN A LITTLE TORQUE WAS APPLIED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269489 ↗
• MalfunctionAug 4, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED: "LOCKING FAILURE OF THE THREE LOCKING SCREWS WERE CONFIRMED. THE SPARE SCREWS WERE INSERTED AND THE SURGERY WAS FINISHED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276618 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR." SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020599 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR." SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020439 ↗
• MalfunctionDec 2, 2020Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent

  AS REPORTED: "VARIAX2 DID NOT LOCK. THE SCREW HEAD WAS CRUSHED EVEN THOUGH THE DRILL GUIDE FITS IN THE PLATE SCREW HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931591 ↗