BEUDAMED
    FDA Enforcement Class II Terminated

    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.

    Recall: Z-0243-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0243-2023
    Event ID
    91002
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Altimate Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    October 4, 2022
    Classification Date
    November 16, 2022
    Termination Date
    August 31, 2023
    Address
    262 W 1st St, N/A, Morton, MN, 56270-1179, United States

    Description

    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.

    Reason

    Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position.

    Code Info

    a. UDI: (01)10858921006062(21)V2005693010, (01)10858921006062(21)V2005693012, (01)10858921006062(21)V2005693015, (01)10858921006062(21)V2005693017, (01)10858921006062(21)V2005694003, (01)10858921006062(21)V2005694009, (01)10858921006062(21)V2005694020, (01)10858921006062(21)V2005695010, (01)10858921006062(21)V2005695011, (01)10858921006062(21)V2005695018, (01)10858921006062(21)V2005695019, (01)10858921006062(21)V2005695020; b. UDI: (01)10858921006079(21)V1005700003, (01)10858921006079(21)V1005700009

    Distribution

    Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.

    Quantity

    14 devices