Update: Hintermann Series H3 Total Ankle Replacement Has A Higher-than-expected Risk Of Device Failure: FDA Safety Communication

Recall Summary The Hintermann Series H3 Total Ankle Replacement device has shown a higher-than-expected rate of failure after implantation. This update provides information for both patients considering this ankle replacement and their healthcare providers about the device's performance and associated risks.

Reason

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-06-17

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/0164edfa-c913-492c-b759-debd8da0042a