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    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 Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 27, 2013

    Medtronic Virtuoso DR, D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code LWS·September 9, 2009

    Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·July 27, 2009

    ARTEGRAFT

    FDA Adverse Event
    Malfunction ·ARTEGRAFT,INC.·Product code LXA·March 16, 2017

    ARTEGRAFT

    FDA Adverse Event
    Malfunction ·ARTEGRAFT, INC.·Product code LXA·March 5, 2020

    STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL GMBH·Product code FTM·September 15, 2017

    Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 55432 USA.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code LWS·March 6, 2012

    CM DRIVE IMPLANT 5.0X11.5 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018

    BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.

    FDA Recall
    Terminated ·Orthofix Inc·Product code NKB·October 22, 2010

    STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL GMBH·Product code FTM·September 15, 2017

    STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL GMBH·Product code FTM·September 15, 2017

    CM DRIVE IMPLANT 4.3X11.5 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018

    AS ENDURO FEMORAL COMPONENT CEMENTED F1R

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code JWH·August 31, 2021

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·December 20, 2018

    ARTEGRAFT

    FDA Adverse Event
    Malfunction ·ARTEGRAFT, INC·Product code LXA·October 17, 2017

    PERMANENT PACING LEAD

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DTB·December 3, 2025

    Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code DZE·March 9, 2017

    CM DRIVE ACQUA IMPLANT 3.5X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018

    ARTEGRAFT

    FDA Adverse Event
    Injury ·ARTEGRAFT, INC·Product code LXA·November 2, 2017

    ARTEGRAFT

    FDA Adverse Event
    Injury ·ARTEGRAFT,INC.·Product code LXA·May 17, 2017