Cadence Total Ankle System 10208103Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556852484), received between Apr 29, 2026 and May 1, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K151459); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Biocompatibility

  IT WAS REPORTED THAT, AFTER A TOTAL ANKLE REPLACEMENT (TAR), PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A RIGHT ANKLE INFECTION WITH ONSET ON (B)(6) 2020. THE ADVERSE EVENT WAS ADDRESSED SURGICALLY WITH AN INCISION AND DRAINAGE (I&D) PROCEDURE, DURING WHICH A POLYETHYLENE LINER AND AN ANTIBIOTIC SPACER WERE PLACED FOR INFECTION MANAGEMENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 25062093 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TAR SURGERY HAD BEEN PERFORMED WITH CADENCE SYSTEM ON (B)(6) 2017, THE CLINICAL SUBJECT HAD A REVISION FUSION REVISION FLAP AND REMOVAL OF EXTERNAL FIXATOR AND SPACER ON (B)(6) 2021. THE ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 25052018 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TOTAL ANKLE REPLACEMENT (TAR) PERFORMED ON (B)(6) 2017, ON (B)(6) 2017 THE PATIENT WAS NOTED TO HAVE MACERATION OVER THE ANTERIOR SURGICAL WOUND BED, WHICH SUBSEQUENTLY DEVELOPED INTO A SUPERFICIAL CELLULITIS AROUND THE ANTERIOR INCISION. THIS ADVERSE EVENT WAS TREATED WITH A COURSE OF ORAL ANTIBIOTICS. FOLLOW-UP ASSESSMENTS DEMONSTRATED PROGRESSIVE IMPROVEMENT, AND THE INFECTION RESOLVED WITH COMPLETE WOUND HEALING.

  Patient problems: Cellulitis

  MAUDE report 25032093 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151459. One submission often covers many models, so check the product and lot details in each record.

• Z-1192-2017 · Jan 20, 2017 · Terminated
  Integra Cadence Total Ankle System
• Z-2086-2016 · Apr 29, 2016 · Terminated
  Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and