BEUDAMED
    FDA Enforcement Class II Terminated

    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

    Recall: Z-2533-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2533-2017
    Event ID
    77277
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    May 4, 2017
    Classification Date
    June 13, 2017
    Termination Date
    March 6, 2018
    Address
    22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

    Reason

    Due to possibility of insufficient sterilization.

    Code Info

    CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)

    Distribution

    US and worldwide: Australia, Finland, France, United Kingdom

    Quantity

    7,939 units total (870 units in US)