Reported Jul 29, 2026 · Ongoing
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm,…
Paragon 28, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Paragon 28, Inc. · 14445 Grasslands Dr · Englewood, CO · 80112-7062
Is this the product you have?
- P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod
- SIZE0.30 mm
- LENGTH800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00889795061577501167202225501167202225UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225 2 00889795061577501167302225501167302225UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225 3 00889795061577501209514725501209514725UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725 4 00889795061577501259627925501259627925UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925 5 00889795061577501275832225501275832225UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225. - Amount recalled
- 514 units
Where it was sold
- Nationwide
Why it was recalled
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
This product could cause temporary or reversible health problems — stop using it.
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