Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
FDA Recall #Z-1256-2024 — Class II — December 21, 2023
Product Description
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Reason for Recall
Medical devices distributed, prior to sterilization
Recalling Firm
Paragon 28, Inc. — Englewood, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1
Distribution
US:CA OUS: None
Code Information
PA23006856
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated