BEUDAMED
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    DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Skull pins w/Torque, DePuy Spine Bremer Halo System Product Code: AC014

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Small Halo Crown, DePuy Spine Bremer Halo System Product Number: HT025

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Standard Skull Rings, DePuy Spine Bremer Halo System Product Code: AC007

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    0 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-010

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    12 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-020

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

    FDA Enforcement
    Class II ·Terminated·SeaSpine Inc·July 2, 2014

    Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.

    FDA Enforcement
    Class II ·Terminated·TITAN SPINE, LLC·August 12, 2015

    Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 12, 2019

    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 25, 2015

    10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·April 6, 2016