Recall Z-1468-2022— Paragon 28, Inc.

Name: FDA recall Z-1468-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-26

Class II · Ongoing

Class II FDA medical device recall by Paragon 28, Inc., initiated 2022-05-26. It names one FDA 510(k) clearance: K171715. Product: HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile). Reason: Due to Titanium plasma coating not present implant..

Recalling firm: Paragon 28, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-26
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K171715 — HammerTube SystemParagon 28·cleared 2018-03-05

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

HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

Reason for recall

Due to Titanium plasma coating not present implant.

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