P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
- Agency
- FDA Device
- Recall date
- Jun 17, 2026
- Status
- Ongoing
- Company
- Paragon 28, Inc.
1. What product was recalled?
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0
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.
Quantity: 514 units
Code or lot text: 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.
- LOT
- Lot Number 501167202225
- LOT
- Lot Number 501167302225
- LOT
- Lot Number 501209514725
- LOT
- Lot Number 501259627925
- LOT
- Lot Number 501275832225.
- LOT
- UDI (01)00889795061577(17)300122(10)501167202225
- LOT
- UDI (01)00889795061577(17)300122(10)501167302225
- LOT
- UDI (01)00889795061577(17)300527(10)501209514725
- LOT
- UDI (01)00889795061577(17)301006(10)501259627925
- LOT
- UDI (01)00889795061577(17)301118(10)501275832225
- RECALL-NUMBER
- Z-2758-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.