DT MedTech, LLC
FDA Regulatory Profile
DT MedTech, LLC appears in FDA public data with 3 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2399-2026, Class II) was initiated on March 24, 2026. Its most recent 510(k) clearance was granted on November 7, 2017.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2399-2026 | Class II | Hintermann Series Talar Implant, Left, Size 2 REF 302112 | March 24, 2026 |
| Z-0403-2019 | Class II | DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prosthe | September 25, 2018 |
| Z-0402-2019 | Class II | DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prosthe | September 25, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171004 | Hintermann Series H2 Total Ankle System | November 7, 2017 |