FDAFDA recall Z-2758-2026 · Jul 29, 2026
Paragon 28, Inc.: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall
Recall found
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 for recall
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 514 units
- Distribution
- US nationwide, Australia, Canada, The Netherlands, and New Zealand
- Recalling firm
- Paragon 28, Inc., Englewood, CO
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-17
Source: openFDA enforcement record Z-2758-2026 · search recall number Z-2758-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.