BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0642-2018 · Initiated October 6, 2017

    Recall

    Recall Number
    Z-0642-2018
    Event Number
    79205
    Firm
    Allen Medical Systems
    FEI Number
    1221538
    Product Code
    JEB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 6, 2017
    Terminated
    April 3, 2019
    Address
    100 Discovery Way, Acton, MA, 01720-4481

    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.

    Action

    In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30 5:00 pm EST.

    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