---
title: "Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-28... — FDA record Z-1458-2022 | Is It on Recall"
description: "Incorrect labeling; There is potential that the drill packaging contains the incorrect part number."
url: https://isitonrecall.com/recall/fda-device-z-1458-2022-paragon-28-inc-system-baby-gorilla-gorilla-plating-system-ref-p99-100-2816-material-stainless-steel/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Dri... — FDA record Z-1458-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
- **Reason**: Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
- **Classification**: Class II
- **Recalling firm**: Paragon 28, Inc.
- **Quantity**: 3 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1458-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1458-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # : HN2204123455; UDI/DI: 00889795053329 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution in the country of UK.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Aug 3, 2022
- **Recall initiation date**: May 18, 2022
- **Center classification date**: Jul 25, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1458-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Paragon 28, Inc. records](https://isitonrecall.com/brand/paragon-28-inc/)