Cadence Total Ankle System 10203001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556850909), received between Feb 9, 2025 and Feb 21, 2026 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TAR, A SPRING ON THE DISTAL TIBIAL ALIGNMENT BLOCK FELL OUT INTO PATIENT'S ANKLE. THE PIECE WAS RECOVERED PICK-UPS AND LAID ON THE TABLE. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410386 ↗
• MalfunctionFeb 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING TOTAL ANKLE REPLACEMENT, THE SCREW IN THE MEDIAL LATERAL TRANSLATION ON ONE [1] DISTAL TIBIAL ALIGNMENT BLOCK BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341195 ↗