BEUDAMED
    FDA Enforcement Class II Ongoing

    Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

    Recall: Z-0177-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0177-2023
    Event ID
    90848
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 9, 2022
    Initiation Date
    September 20, 2022
    Classification Date
    November 3, 2022
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

    Reason

    the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

    Code Info

    UDI/DI 00615521002725, Lot Number: 22-123

    Distribution

    MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

    Quantity

    2 units