BEUDAMED
    FDA Enforcement Class II Terminated

    Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT

    Recall: Z-0740-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0740-2022
    Event ID
    89588
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nextremity Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    January 13, 2022
    Classification Date
    March 9, 2022
    Termination Date
    May 24, 2024
    Address
    1195 Polk Dr, N/A, Warsaw, IN, 46582-8602, United States

    Description

    Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT

    Reason

    During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

    Code Info

    Lot Numbers: 1574701, 158961 UDI: 00817701026372

    Distribution

    US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.

    Quantity

    24 units