BEUDAMED
    FDA Enforcement Class II Terminated

    Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.

    Recall: Z-1350-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1350-2018
    Event ID
    79559
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neuropro Spinal Jaxx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 18, 2018
    Initiation Date
    January 18, 2018
    Classification Date
    April 10, 2018
    Termination Date
    July 13, 2018
    Address
    6337 Falling Brook Dr, Burke, VA, 22015-4031, United States

    Description

    Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.

    Reason

    The implant size is incorrectly etched on the implant. The size listed on the box is correct.

    Code Info

    Lot 1599, Expiration date: 10/03/2018

    Distribution

    The devices were distributed in California.

    Quantity

    6