Paragon 28, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1458-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 18, 2022

Date Posted: August 3, 2022

Recall Number: Z-1458-2022

Event ID: 90478

Reason for Recall:

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

Status: Ongoing

Product Quantity: 3 units

Code Information:

Lot # : HN2204123455; UDI/DI: 00889795053329

Distribution Pattern:

International distribution in the country of UK.

Voluntary or Mandated:

Voluntary: Firm initiated