BEUDAMED
    FDA Enforcement Class II Ongoing

    Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.

    Recall: Z-1184-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1184-2024
    Event ID
    93840
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medagent Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 6, 2024
    Initiation Date
    December 21, 2023
    Classification Date
    February 23, 2024
    Address
    264 Lafayette Rd Ste 7, Portsmouth, NH, 03801-5430, United States

    Description

    Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.

    Reason

    Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.

    Code Info

    Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673

    Distribution

    TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK

    Quantity

    84 units