FDA-Device2022-08-03Class II

Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

Paragon 28, Inc.
Hazard

Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

Sold states
International distribution in the country of UK.
Affected count
3 units
Manufactured in
14445 Grasslands Dr, Englewood, CO, United States
Products
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2022

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