P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall (Paragon 28, Inc.)
Medical deviceClass IIOngoing
Summary: Paragon 28, Inc. is recalling 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.
What is being recalled
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.
Why
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US nationwide, Australia, Canada, The Netherlands, and New Zealand
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2758-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 17, 2026 |
| Reported | July 29, 2026 |
| Company | Paragon 28, Inc. |
| Company location | Englewood, CO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 514 units |
More recalls from Paragon 28, Inc. · all medical device recalls · recalls from June 2026