BEUDAMED
    FDA Enforcement Class II Terminated

    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.

    Recall: Z-1562-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1562-2022
    Event ID
    90629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    July 15, 2022
    Classification Date
    August 22, 2022
    Termination Date
    August 6, 2024
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.

    Reason

    The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

    Code Info

    (1) M8124 - Lot 57372551 / exp 06/06/2032; Lot 57285721 / exp 05/22/2032; Lot 57369651 / exp 06/06/2032; Lot 57497652 / exp 6/27/2032; GTIN: 00749756780728; (2) M8125 - Lot 5746744 / exp 6/20/2032; Lot 57419195 / exp 6/13/2032; Lot 57420031 / exp 6/14/2032; GTIN: 00749756780735; (3) M8136 - Lot 57501121 / exp 6/27/2032; GTIN: 00749756837828; (4) M8137 - Lot 57462151 / exp 6/20/2032; GTIN: 00749756849234.

    Distribution

    US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.

    Quantity

    36 eaches and 7 pairs