DT MedTech, LLC – FDA 483, May 28, 2026

An FDA inspection of DT MedTech, LLC, a specification developer, revealed significant deficiencies in their quality system, particularly concerning the Hintermann Series H3 Total Ankle Replacement System. Observations included inadequate corrective action procedures, failures in integrating post-production feedback into risk management, and ambiguous design input requirements. These issues highlight a lack of robust controls over outsourced processes, post-market surveillance, and product design, potentially impacting device safety and effectiveness.