Tag: device_failure

FDA Recommends Alternatives to Hintermann Ankle Replacement System Due to Failure Risks

3 Jun 2026 2:05 p.m. · Source: US Food and Drug Administration

The FDA advises considering alternative treatments to the Hintermann Series H3 Total Ankle Replacement System due to elevated long-term risks. Device failure, revision surgery, and polyethylene fracture are among the concerns for the DT MedTech LLC product.

Health Politics and Government Medical Science Federal Government Legal Social Issues Hintermann Series H3 Total Ankle Replacement FDA DT MedTech LLC Device Failure Revision Surgery Polyethylene Fracture Food Recalls Drugs