Z-2488-2021 Class II Terminated

Recalled by Paragon 28, Inc. — Englewood, CO

Recall Details

Product Type
Devices
Report Date
September 29, 2021
Initiation Date
July 30, 2021
Termination Date
December 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 drill bits

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.

Distribution Pattern

U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A

Code Information

Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550