Cadence Total Ankle System 10208101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556852460), received between Apr 29, 2026 and Apr 29, 2026 — classified as 2 injuries.

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

• InjuryApr 29, 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 EXPERIENCES LATERAL RIGHT ANKLE PAIN FOR APPROXIMATELY A YEAR. THE SUBJECT REPORTED WORSENING PAIN, DESCRIBED AS SHARP AND SEVERE, RATED 8/10, AND EXACERBATED BY WEIGHT BEARING AND AMBULATION AT THE CLINICAL FOLLOW ON (B)(6) 2023. THIS ADVERSE EVENT WAS EVALUATED FOR FURTHER DIAGNOSTIC WITH A CT SCAN TO ASSESS POSSIBLE LATERAL GUTTER IMPINGEMENT AND PRESCRIBED A MEDIAL HEEL WEDGE AS INTERIM MANAGEMENT. THE CURRENT OUTCOME OF THE SUBJECT IS ONGOING.

  Patient problems: Pain

  MAUDE report 25038279 ↗
• InjuryApr 29, 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 EXPERIENCES A TIBIA FRACTURE FOLLOWING MULTIPLE POSTOPERATIVE FALLS, PATIENT WAS EVALUATED IN CLINIC ON (B)(6) 2017, AND A CT SCAN REVEALED A MINIMALLY DISPLACED POSTERIOR TIBIA FRACTURE. CLINICAL MANAGEMENT CONSISTED OF EXTENDED IMMOBILIZATION, WITH CASTING CONTINUED FOR AN ADDITIONAL THREE WEEKS BEYOND THE ORIGINAL POSTOPERATIVE PLAN. NO SURGICAL REVISION WAS REQUIRED AND FOLLOW-UP IMAGING DEMONSTRATED FRACTURE HEALING. THE ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017.

  Patient problems: Bone Fracture(s); Fall; Periprosthetic fracture

  MAUDE report 25038162 ↗

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