BEUDAMED
    FDA Enforcement Class II Terminated

    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.

    Recall: Z-2136-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2136-2014
    Event ID
    68863
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    X Spine Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 13, 2014
    Initiation Date
    July 11, 2014
    Classification Date
    August 1, 2014
    Termination Date
    August 14, 2014
    Address
    452 Alexandersville Rd, N/A, Miamisburg, OH, 45342-3658, United States

    Description

    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.

    Reason

    Revision B of the tissue shields of the device was 7 mm longer than the previous design.

    Code Info

    Part numbers X079-0096 and X079-0097 with Lot #12320

    Distribution

    US Distribution including the states of FL and MO.

    Quantity

    A total of 5-pieces of each part number distributed