BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2405-2021 · Initiated July 27, 2021

    Recall

    Recall Number
    Z-2405-2021
    Event Number
    88399
    Firm
    Clarus Medical, Llc
    FEI Number
    1000116142
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 27, 2021
    Terminated
    September 15, 2022
    Address
    13355 10th Ave N, Ste 110, Minneapolis, MN, 55441-5554

    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.

    Action

    The affected Domestic customers, Domestic/International Distributors will be notified with a Field Safety Notice. Domestic/International distributors will also include a request for a list of the Distributor s customers.

    Distribution

    Distribution in US - 18 accounts 1 foreign account

    Quantity

    858 units