BEUDAMED
    FDA Enforcement Class II Terminated

    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

    Recall: Z-0707-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0707-2022
    Event ID
    89555
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brasseler USA, Medical L.L.C.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 9, 2022
    Initiation Date
    January 28, 2022
    Classification Date
    March 1, 2022
    Termination Date
    February 3, 2023
    Address
    1 Brasseler Blvd, Savannah, GA, 31419-9576, United States

    Description

    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

    Reason

    One lot of product was distributed in unsealed packaging

    Code Info

    UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX

    Distribution

    US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.

    Quantity

    231 units