FDA Device recall Z-1458-2022
Paragon 28, Inc
- FDA Device
- Class II
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of Paragon 28, Inc by Paragon 28, citing incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1458-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-18 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Paragon 28 |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot # : HN2204123455; UDI/DI: 00889795053329 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1458-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.