BEUDAMED
    FDA Enforcement Class II Terminated

    Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument

    Recall: Z-0911-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0911-2022
    Event ID
    89764
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nextremity Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 20, 2022
    Initiation Date
    February 10, 2022
    Classification Date
    April 12, 2022
    Termination Date
    October 10, 2024
    Address
    1195 Polk Dr, N/A, Warsaw, IN, 46582-8602, United States

    Description

    Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument

    Reason

    Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

    Code Info

    Lot Number: 168117318C, 168125017D UDI: 00817701020004

    Distribution

    Distribution US Nationwide, Japan, and the Netherlands

    Quantity

    459 units