Phantom TTC Nail, 10.0 X 200mm, Right

FDA Recall #Z-1254-2024 — Class II — December 21, 2023

Recall #Z-1254-2024 Date: December 21, 2023 Classification: Class II Status: Ongoing

Product Description

Phantom TTC Nail, 10.0 X 200mm, Right

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

Distribution

US:CA OUS: None

Code Information

PA23005925

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated