Cadence Total Ankle System 10207211Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556852422), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL ANKLE REPLACEMENT SURGERY WAS PERFORMED ON (B)(6) 2018 WITH A CADENCE TOTAL ANKLE SYSTEM, THE PATIENT PRESENTED ANTERIOR IMPINGEMENT, TIBIALIS POSTERIOR ADHERENCES TO THE MALLEOLUS AND TOO MUCH PRESSURE (M5). THIS ADVERSE EVENT WAS TREATED WITH PHYSICAL THERAPY, A PERCUTANEOUS OSTEOTOMY OF M5, RELEASE OF THE TIBIALIS POSTERIOR TENDINOPATHY AND AN ANTERIOR ANKLE ARTHROSCOPY. THIS ADVERSE EVENT IS ONGOING.

  Patient problems: Adhesion(s); Joint Impingement; Rupture

  MAUDE report 17099817 ↗

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