FDA recall Z-1458-2022

Paragon 28, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

International distribution in the country of UK.

Key facts

Status
Ongoing
Initiation date
2022-05-18
Report date
2022-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Englewood, CO, United States

Primary source

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