BEUDAMED
    FDA Enforcement Class II Ongoing

    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

    Recall: Z-1036-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1036-2022
    Event ID
    89868
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2022
    Initiation Date
    March 22, 2022
    Classification Date
    May 6, 2022
    Address
    2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States

    Description

    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

    Reason

    Product was sterilized with a higher than specification EO concentration.

    Code Info

    1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280

    Distribution

    US Nationwide distribution in the states of IL, MO, NE, and TX.

    Quantity

    72 packs