BEUDAMED
    FDA Enforcement Class II Terminated

    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

    Recall: Z-0642-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0642-2018
    Event ID
    79205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Allen Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    October 6, 2017
    Classification Date
    February 20, 2018
    Termination Date
    April 3, 2019
    Address
    100 Discovery Way, N/A, Acton, MA, 01720-4481, United States

    Description

    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

    Reason

    The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

    Code Info

    Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544938 535274 536028 536454 539588 544939 535386 536029 536455 539589 544940 535387 536030 536456 539794 546200

    Distribution

    Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.

    Quantity

    161 units total