BEUDAMED
    FDA Enforcement Class II Terminated

    Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

    Recall: Z-1458-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1458-2020
    Event ID
    84924
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nextremity Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2020
    Initiation Date
    February 12, 2020
    Classification Date
    March 9, 2020
    Termination Date
    December 17, 2020
    Address
    6210 N Buffalo St, Warsaw, IN, 46580, United States

    Description

    Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

    Reason

    Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant

    Code Info

    Lot Number: 168117318B UDI: 00817701020011

    Distribution

    International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.

    Quantity

    190 units