Official recall notice
FDA DeviceClass IINotable
FDA Recall: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm
- Recall date
- 2026-07-29
- Brand
- Paragon 28, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Product description
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Affected products
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.