FDA recall Z-2488-2021

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-07-30

Report date

2021-09-29

Termination date

2021-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2488-2021