FDAClass II · Medical device · Recall Z-2758-2026 · Recalled July 29, 2026

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall — Paragon 28, Inc.

Agency report date: July 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM
Company / brand: Paragon 28
Lot / serial / date codes: UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand

Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2758-2026
Brand: Paragon 28
Classification: Class II
Units affected: 514 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM

Companies & origin

Recalling firm location: Englewood, CO, United States
Firm address: 14445 Grasslands Dr, N/A, 80112-7062

Identifying details (verbatim from the notice)

Product codes / lots: UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99276
Recall initiated: June 17, 2026
FDA classified: July 17, 2026
FDA report date: July 29, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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