BEUDAMED
    FDA Enforcement Class II Terminated

    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    Recall: Z-1503-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1503-2020
    Event ID
    84252
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TeDan Surgical Innovations LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 25, 2020
    Initiation Date
    February 18, 2019
    Classification Date
    March 17, 2020
    Termination Date
    January 12, 2021
    Address
    12615 W Airport Blvd Ste 200, Sugar Land, TX, 77478-6203, United States

    Description

    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    Reason

    The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.

    Code Info

    Item #: D-0012 Lot #: 2018011601

    Distribution

    Worldwide.

    Quantity

    49 boxes (245 individual screws)