BEUDAMED
    FDA Recall Open, Classified

    AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

    Recall: Z-3210-2024 · Initiated August 23, 2024

    Recall

    Recall Number
    Z-3210-2024
    Event Number
    95274
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    OVE
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    August 23, 2024
    Posted
    September 23, 2024
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

    Reason

    Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.

    Action

    Stryker issued Medical Device Correction letter on 8/23/24 to Surgeons via Fed'X. Letter states reason for recall, health risk and action to take: Our records indicate that you are a new user of the AVS-Anchor C system since the eIFU was updated to Revision 5 in January 2023. Please review the Product Correction Notification and the updated eIFU (Revision 6). This communication is being made for notification purposes only; there are no product(s) to be returned for this matter. 2. Use the Business Reply Form to acknowledge receipt of this notification letter. 3. Return the enclosed Business Reply Form by email to: [email protected] to confirm receipt of this notification. 4. If you desire additional training associated with these instructions, please contact our Regulatory Compliance team by calling 201.749.8090 or by email at [email protected], or contact your local Sales representative. Completing this action by the target date September 13, 2024 and regret any inconvenience that may be caused

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    8,589 units