FDAClass IIAugust 3, 2022

Paragon 28 recall: Labeling Error

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

Why was Paragon 28 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # : HN2204123455; UDI/DI: 00889795053329

Product
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Recalling firm
Paragon 28, Inc.
Quantity
3 units
Distribution
International distribution in the country of UK.
Recall date
August 3, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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