FDAFDA · Food and drugs·Recall number Z-2758-2026
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.
Published July 29, 2026 · Recall initiated: June 17, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Paragon 28, Inc.
- Distributor
- US nationwide, Australia, Canada, The Netherlands, and New Zealand
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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