P28 PHANTON INTRAMEDULLARY NAIL SYSTEM — Class II medical device recall Z-2758-2026
Ongoing recall by Paragon 28, Inc., reported 2026-07-29, distributed nationwide. Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch pa
| Recall number | Z-2758-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragon 28, Inc., Englewood, CO, United States |
| Recall initiated | 2026-06-17 |
| Classified | 2026-07-17 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NL, NZ |
| Quantity | 514 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00889795061577 |
| Lot numbers | 501167202225, 501167302225, 501209514725, 501259627925, 501275832225 |
| Model numbers | P31-955-1800-S |
Product
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Reason for recall
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
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-2758-2026. 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.