FDA MedWatch - UPDATE: Hintermann Series H3 Total Ankle Replacement System and Long-Term Risk of Device Failure: FDA Safety Communication
Published: 06/04/2026
Sources:
- Food and Drug Administration
Relevant To:
- Ambulatory Surgical Centers,
- Critical Access Hospitals,
- Hospitals,
- Ambulatory Care
The FDA has updated the “Hintermann Series H3 Total Ankle Replacement System and Long-Term Risk of Device Failure” Safety Communication to alert patients, caregivers, and health care providers of the elevated long-term risk of device failure, higher-than-expected risk of revision surgery, and risk of polyethylene fracture (plastic breakage) observed in the Hintermann Series H3 Total Ankle Replacement (TAR) System, manufactured by DT MedTech LLC.
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