BEUDAMED
    FDA Recall Open, Classified

    LITe Decompression Snake Arm, REF 48080230

    Recall: Z-0610-2024 · Initiated November 1, 2023

    Recall

    Recall Number
    Z-0610-2024
    Event Number
    93573
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 1, 2023
    Posted
    December 21, 2023
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    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.

    Action

    Stryker issued Urgent Medical Device Correction on 11/20/2023 notifying customers of removal of lot 227764 of the LITe Decompression Tube Snake Arm, catalog number 48080230. A portion of one lot of the LITe Decompression Tube Snake Arm was manufactured with the incorrect clamp component. As a result, the affected Snake Arms cannot attach to the arm post shaft. Customers are to review inventory and remove units from points of use for return to Stryker, share this information with appropriate personnel and return the Business Reply form to [email protected]. If you have any questions or concerns, please contact Regulatory Compliance at (201) 749-8090.

    Distribution

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

    Quantity

    9