Device product
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Z-0402-2019
Product summary
- Firm
- DT MedTech, LLC
- Event
- Event 81293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 units
- Official record key
device-enforcement:Z-0402-2019
Official wording
Reason: Incorrect package labeling identifying the device
Code information: Lot: AAADP
Distribution pattern: Australia, Ireland, Korea, Germany
Derived failure modes
-
Labeling or packaging
Incorrect package