Device product
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Z-1458-2022
Product summary
- Firm
- Paragon 28, Inc.
- Event
- Event 90478
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1458-2022
Official wording
Reason: Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Code information: Lot # : HN2204123455; UDI/DI: 00889795053329
Distribution pattern: International distribution in the country of UK.
Derived failure modes
-
Labeling or packaging
Incorrect labeling