Recall Z-2488-2021— Paragon 28, Inc.

Name: FDA recall Z-2488-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-30

Class II · Terminated

Class II FDA medical device recall by Paragon 28, Inc., initiated 2021-07-30, terminated 2021-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630. Reason: A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath..

Recalling firm: Paragon 28, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-07-30
Terminated: 2021-12-15
Firm location: Englewood, CO, United States

Product description

Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630

Reason for recall

A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.

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