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Paragon 28, Inc. recalls Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Recalled September 29, 2021 · FDA recall Z-2488-2021 · Paragon 28
Hazard
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. · FDA Class II
Units
14 drill bits
Sold at
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
Description
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.
Product
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Manufacturer(s)
Paragon 28, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →