Class II — DT MedTech, LLC
| Recalling firm | DT MedTech LLC |
|---|---|
| Registered facility | DT MEDTECH LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect package labeling identifying the device |
| Product | DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint. |
| Quantity | 1 |
| Distribution | Australia, Ireland, Korea, Germany |
| Initiated | 2018-09-25 |
| Classified | 2018-11-07 |
| Terminated | 2019-12-05 |
| Recall number | Z-0403-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DT MedTech, LLC (Z-0403-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81293/
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