VariAx 54-25424Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252042495), received between Dec 8, 2022 and Dec 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 16, 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.

• InjuryDec 8, 2022Off-Label Use; Device Damaged Prior to Receipt by User; Off-Label Use; Device Damaged Prior to Receipt by User

  AS REPORTED: "WE HAD ORDERED ON 05/07/2022, 2 VARIAX PALMAR PLATES REFERENCE 54-254 25.5 AND 54-254 24.5. ON THE OTHER HAND, YOU HAD SENT THE REFERENCES 54-254 26 AND 54-254 24: REFERENCES WHICH DO NOT CORRESPOND TO THE ORDER. WE HAVE NOT RECEIVED ANY INFORMATION FROM YOU ON THIS "INCONSISTENCY": SENDING ANOTHER REFERENCE WITHOUT INFORMATION, NON-EXISTENT REFERENCES FROM YOU. INDEED, WE SHOULD HAVE ORDERED REFERENCES 54-254 26.S AND 54-254 24.S BECAUSE REFERENCES 54-254 24.5 AND 54-254 24.5 DO NOT EXIST. UPON RECEIPT, WE DID NOT OBSERVE THIS SPONTANEOUS MODIFICATION ON YOUR PART; CONSEQUENTLY, THE NON-STERILE PLATES RECEIVED, INITIALLY REQUESTED BY THE HOSPITAL AS STERILE, FOLLOWED THE CIRCUIT OF STERILE IMPLANTABLE MEDICAL DEVICES WITHIN OUR ESTABLISHMENT. THIS RESULTED IN THE IMPLANTATION OF A NON-STERILE DM IN A PATIENT, AS WELL AS THE REMOVAL OF THIS PLATE DURING A SECOND INTERVENTION.".ONLY 1 PLATE WAS IMPLANTED THEN EXPLANTED (54-25424)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947200 ↗