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    Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors.

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code KWP·October 5, 2006

    Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NKB·April 13, 2010

    Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HXC·November 7, 2008

    ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code KWQ·August 24, 2004

    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code HWX·May 21, 2004

    Instinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code NKB·February 12, 2016

    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code KWP·February 3, 2016

    Universal Clamp System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code NKB·February 12, 2016

    Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HXX·May 20, 2011

    Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HXX·May 20, 2011

    Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code MNI·January 12, 2009

    TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXH·October 21, 2010

    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

    Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States. The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not intended to replace normal body structures.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWP·September 21, 2009

    Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.

    FDA Recall
    Terminated ·Zimmer Biomet Spine, Inc·Product code MAX·June 30, 2016

    Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.

    FDA Recall
    Terminated ·Zimmer Biomet Spine, Inc·Product code MAX·June 30, 2016

    Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Recall
    Terminated ·Zimmer Biomet Spine Inc.·Product code KWQ·July 30, 2018

    Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.

    FDA Recall
    Terminated ·Zimmer Biomet Spine Inc.·Product code KWP·July 30, 2018

    Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Recall
    Terminated ·Zimmer Biomet Spine Inc.·Product code NKB·July 30, 2018

    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017

    FDA Recall
    Terminated ·Zimmer Biomet Spine Inc.·Product code LYQ·May 10, 2017