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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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