BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2488-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2488-2021
    Event ID
    88553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    July 30, 2021
    Classification Date
    September 17, 2021
    Termination Date
    December 15, 2021
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062, United States

    Description

    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.

    Code Info

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

    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

    Quantity

    14 drill bits