BEUDAMED
    FDA Recall 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 · Initiated January 18, 2018

    Recall

    Recall Number
    Z-1350-2018
    Event Number
    79559
    Firm
    Neuropro Spinal Jaxx
    FEI Number
    3013378904
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    January 18, 2018
    Terminated
    July 13, 2018
    Address
    6337 Falling Brook Dr, Burke, VA, 22015-4031

    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.

    Action

    The firm called the consignee using a phone script. Additional information requested regarding whether any instructions were provided to the consignee regarding what to do with the recalled devices.

    Distribution

    The devices were distributed in California.

    Quantity

    6