DT Medical -Hintermann Series H3 Poly Inlay — Class II medical device recall Z-0402-2019
Terminated recall by DT MedTech, LLC, reported 2018-11-14. Incorrect package labeling identifying the device
| Recall number | Z-0402-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DT MedTech, LLC, Towson, MD, United States |
| Recall initiated | 2018-09-25 |
| Classified | 2018-11-07 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2019-12-05 |
| Countries outside the US | AU, DE, IE, KR |
| Quantity | 54 units |
| Reason classes | labeling |
| Model numbers | 300305 |
Product
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Reason for recall
Incorrect package labeling identifying the device
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0402-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.