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    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MAX·November 22, 2016

    Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.

    FDA Recall
    Terminated ·Abaxis Inc·Product code JFY·November 16, 2009

    Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V). The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWQ·October 9, 2013

    Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; Product is manufactured and distributed by Abaxis, Incorporated, Union City, CA The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented selfcontained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.

    FDA Recall
    Terminated ·Abaxis, Incorporated·Product code CKA·November 19, 2010