Device product
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Z-0403-2019
Product summary
- Firm
- DT MedTech, LLC
- Event
- Event 81293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0403-2019
Official wording
Reason: Incorrect package labeling identifying the device
Code information: Lot: AAAEM
Distribution pattern: Australia, Ireland, Korea, Germany
Derived failure modes
-
Labeling or packaging
Incorrect package