BEUDAMED
    FDA Enforcement Class II Terminated

    Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.

    Recall: Z-2945-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2945-2018
    Event ID
    80688
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ceterix Orthopedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    May 16, 2018
    Classification Date
    August 28, 2018
    Termination Date
    August 24, 2020
    Address
    6500 Kaiser Dr Ste 120, N/A, Fremont, CA, 94555-3662, United States

    Description

    Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.

    Reason

    Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.

    Code Info

    Lot#M180018

    Distribution

    United States distribution.

    Quantity

    96 units