BEUDAMED
    FDA Enforcement Class II Terminated

    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    Recall: Z-1506-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1506-2020
    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

    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended 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 #: DS-0024 Lot #s: 2018022801 2018050801

    Distribution

    Worldwide.

    Quantity

    Total=146 boxes (48 boxes for Lot 2018022801 and 98 boxes for Lot 2018050801)