BEUDAMED
    FDA Enforcement Class II Ongoing

    LITe Decompression Snake Arm, REF 48080230

    Recall: Z-0610-2024 · Reported December 27, 2023

    Enforcement

    Recall Number
    Z-0610-2024
    Event ID
    93573
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 27, 2023
    Initiation Date
    November 1, 2023
    Classification Date
    December 21, 2023
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    LITe Decompression Snake Arm, REF 48080230

    Reason

    Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.

    Code Info

    UDI-DI (GTIN): 07613327263909, lot # 227764.

    Distribution

    US: MD, MI, NM, TX & OUS: Canada & France.

    Quantity

    9