Paragon 28 Phantom TTC Nail distributed prior to sterilization
Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.
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: FDA Class II recall of a non-sterile surgical implant device. Although no illnesses or injuries have been reported, non-sterile surgical nails represent a risk-of-harm product where infection is a theoretical but significant threat if implanted.
Plain-English summary
Paragon 28, Inc. is recalling Phantom TTC Nails (10.0 X 200mm, Right) with lot code PA23005925 that were distributed prior to sterilization. Non-sterile medical devices pose a potential infection risk, particularly for implantable surgical products. Medical devices must be properly sterilized before distribution to patients.
The recalled nails were distributed in California. Patients and healthcare providers who may have received this product should consult with their healthcare provider regarding potential exposure to non-sterile devices.
The recalled product
- Product
- Phantom TTC Nail, 10.0 X 200mm, Right
- Manufacturer
- Paragon 28, Inc.
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)
- PA23005925
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
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