BEUDAMED
    FDA Enforcement Class II Terminated

    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.

    Recall: Z-0470-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0470-2021
    Event ID
    86608
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Micro-Tech Usa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2020
    Initiation Date
    October 5, 2020
    Classification Date
    November 18, 2020
    Termination Date
    December 2, 2021
    Address
    2855 Boardwalk St, N/A, Ann Arbor, MI, 48104-6715, United States

    Description

    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.

    Reason

    FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.

    Code Info

    Lots M190808231 M191018231 M191224231 M200305232

    Distribution

    US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.

    Quantity

    2420 pieces