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

Source: https://www.keypedia.com/records/483/dt-medtech-llc/21adcaa5-1655-4716-9b97-ec3aa2837b0b

> FDA 483 for DT MedTech, LLC on May 28, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DT MedTech, LLC
- Inspection Date: 2026-05-28
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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.

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/dt-medtech-llc/0f6b0f0f-322c-4b5c-a5dc-500309b79ce4

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea