Is Paragon 28, Inc. recalled?

Yes — a recall has been published. Reason: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

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.

Check the device or its packaging for

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.

Why: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Distributed: US nationwide, Australia, Canada, The Netherlands, and New Zealand
Company: Paragon 28, Inc.
Announced: 29 July 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 17 June 2026

Source: FDA record Z-2758-2026 · retrieved 17 July 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.