← FDA ENFORCEMENT
Z-2758-2026Class II

Paragon 28, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Paragon 28, Inc.
Product type
Device
Status
Ongoing
Report date
2026-07-29
Distribution
US nationwide, Australia, Canada, The Netherlands, and New Zealand
Firm state
CO
Product quantity
514 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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.

Code / lot info

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.

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →