Paragon 28 — Class II medical device recall Z-1458-2022
Ongoing recall by Paragon 28, Inc., reported 2022-08-03. Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
| Recall number | Z-1458-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragon 28, Inc., Englewood, CO, United States |
| Recall initiated | 2022-05-18 |
| Classified | 2022-07-25 |
| Reported by FDA | 2022-08-03 |
| Countries outside the US | GB |
| Quantity | 3 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889795053329 |
| Lot numbers | HN2204123455 |
| Model numbers | P99-100-2816 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1458-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.