BEUDAMED
    FDA Enforcement Class II Terminated

    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    Recall: Z-0423-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0423-2016
    Event ID
    72646
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    November 10, 2015
    Classification Date
    December 18, 2015
    Termination Date
    September 8, 2016
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    Reason

    The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

    Code Info

    all lots

    Distribution

    Worldwide Distribution: US (nationwide) and country of: Canada.

    Quantity

    41