BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2945-2018 · Initiated May 16, 2018

    Recall

    Recall Number
    Z-2945-2018
    Event Number
    80688
    Firm
    Ceterix Orthopedics, Inc.
    FEI Number
    3009131204
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 16, 2018
    Terminated
    August 24, 2020
    Address
    6500 Kaiser Dr, Ste 120, Fremont, CA, 94555-3662

    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.

    Action

    Ceterix Orthopaedics notified customers via an "Urgent Field Safety Notice: for NovoCut Suture Manager. The letter dated May 16, 2018 provided the following: Details on affected devices, Description of the problem, Risks to Health, Actions to be taken by the customer, and Contact reference person.

    Distribution

    United States distribution.

    Quantity

    96 units