Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM
- Recalling company
- Paragon 28, Inc.
- Product
- 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.
- Reason
- Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 17, 2026
- Reported
- Jul 29, 2026
- Distribution
- US nationwide, Australia, Canada, The Netherlands, and New Zealand
- Status
- Ongoing
- Quantity
- 514 units
- Lot / 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.
- Company location
- Englewood, CO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2758-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2758-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.