BEUDAMED
    FDA Enforcement Class II Terminated

    Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

    Recall: Z-2405-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2405-2021
    Event ID
    88399
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clarus Medical, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    July 27, 2021
    Classification Date
    September 2, 2021
    Termination Date
    September 15, 2022
    Address
    13355 10th Ave N Ste 110, N/A, Minneapolis, MN, 55441-5554, United States

    Description

    Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

    Reason

    The sterile barrier seal may be compromised.

    Code Info

    Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022

    Distribution

    Distribution in US - 18 accounts 1 foreign account

    Quantity

    858 units