Paragon 28 Phantom TTC Nail Recalled Due to Improper Sterilization
Paragon 28 has recalled the Phantom TTC Nail (11.5 X 250mm, RIGHT, REF: P31-615-250R) distributed in California prior to sterilization. Non-sterilized surgical implants pose a risk of infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm product (surgical implant) where sterilization failure creates infection risk. No illnesses or injuries have been reported, making this a theoretical hazard rather than a confirmed harm event.
Plain-English summary
Paragon 28, Inc. has recalled the Phantom TTC Nail (Model 11.5 X 250mm, RIGHT, Reference P31-615-250R, Code PA23006856) due to distribution prior to sterilization.
Orthopedic nails intended for surgical implantation must be sterile to prevent infection. This recall was issued because affected units were distributed before undergoing required sterilization. Healthcare facilities or individuals who received this product should immediately discontinue use and contact Paragon 28, Inc. for information about device replacement or return.
The recalled product
- Product
- Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
- Manufacturer
- Paragon 28, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- PA23006856
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Paragon 28, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Paragon 28, Inc.
See all →- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighFibula nails recalled over out of specification thread depths on the implant
FDA (Devices) · 2025-12-10
- HighParagon 28 Phantom TTC Nail distributed prior to sterilization
FDA (Devices) · 2024-03-13
Same hazard · sterilization failure
See all →- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22