Recall Z-1256-2024— Paragon 28, Inc.

Name: FDA recall Z-1256-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Class II · Ongoing

Class II FDA medical device recall by Paragon 28, Inc., initiated 2023-12-21. It names one FDA 510(k) clearance: K210869. Product: Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R. Reason: Medical devices distributed, prior to sterilization.

Recalling firm: Paragon 28, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-21
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K210869 — Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.·cleared 2021-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.