Device product
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Z-2052-2020
Product summary
- Event
- Event 85434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 stents
- Official record key
device-enforcement:Z-2052-2020
Official wording
Reason: The incorrect label was placed on both the primary and secondary package.
Code information: Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084
Distribution pattern: International the country of Japan.
Derived failure modes
-
Labeling or packaging
incorrect label