STERLING CUDA C9254Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854017531), received between Aug 30, 2021 and Aug 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionAug 30, 2021Break; Break

  ON BEHALF OF THEIR CUSTOMER, CONMED (B)(4) REPORTED ISSUES WITH THE 4.2MM STERLING CUDA # C9254, LOT 1154878, RECENTLY EXPERIENCED BY (B)(6) ON (B)(6) 2021. INFORMATION RECEIVED INDICATES SHAVER BROKE DURING USE IN AN ACHILLES PROCEDURE. IT IS NOTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER 4.2 CUDA WITH NO IMPACT OR INJURY TO THE PATIENT. TO DATE, ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT PER THE REPORTER, AT THIS TIME THERE IS NO OTHER INFORMATION AVAILABLE. THIS INCIDENT WILL BE REPORTED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE BECAUSE CLARIFICATION OF THE TERM "BROKE" AND IF THERE WAS PATIENT CONTACT CAN NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387699 ↗