Neuropro Spinal Jaxx - Spinal Jaxx Interbody Fusion Device - Class 2 Recall
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 Jax...
Source: Medical Device Recalls - April 11, 2018 Category: Medical Devices Source Type: alerts

SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and ...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts

SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and ...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts

SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and ...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts

SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW 4.0 MM, 04 L14, REF TRYPS40 14S - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and ...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts

SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and ...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts

SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and ...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts

SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and ...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts

Genesys Orthopedics Systems, LLC - Genesys spine, Binary Screwdriver - Class 2 Recall
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studie...
Source: Medical Device Recalls - October 20, 2017 Category: Medical Devices Source Type: alerts

XTANT MEDICAL INC - Fortex Pedicle Screw System - Class 2 Recall
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sac...
Source: Medical Device Recalls - April 28, 2017 Category: Medical Equipment Source Type: alerts

Ulrich Medical USA Inc - uNion CPS - Class 2 Recall
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 27, 2017 Category: Medical Equipment Source Type: alerts

Zimmer Biomet Spine, Inc - Altius MINI OCT Posterior Spinal Fixation System - Class 2 Recall
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixati...
Source: Medical Device Recalls - March 29, 2017 Category: Medical Equipment Source Type: alerts

Kiscomedica S.A. - LVarlock Cage/Trial Implant Holder - Class 2 Recall
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-V...
Source: Medical Device Recalls - February 28, 2017 Category: Medical Equipment Source Type: alerts

Interventional Spine Inc - G3 Opticage Expandable Interbody Fusion Device - Class 2 Recall
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 deg...
Source: Medical Device Recalls - January 4, 2017 Category: Medical Equipment Source Type: alerts

Biomet Spine, LLC - Solitaire Anterior Spinal System - Class 2 Recall
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-...
Source: Medical Device Recalls - March 26, 2016 Category: Medical Equipment Source Type: alerts

OrthoPediatrics Corp - Response 5.5/6.0 Spine System - Class 2 Recall
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 9, 2016 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Cervical Plate - Class 2 Recall
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 15, 2015 Category: Medical Equipment Source Type: alerts

X Spine Systems Inc - Xpress System Pedicle Screw Assembly, 5.5 x 55mm - Class 2 Recall
Xpress System Pedicle Screw Assembly, 5.5 x 55mm . is an internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. Each Xpress pedicle screw assembly consists of a pedicle screw, yoke, screw top and threaded setscrew. The Xpress Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment ...
Source: Medical Device Recalls - April 23, 2015 Category: Medical Equipment Source Type: alerts

Genesys Orthopedics Systems, LLC - The TiLock Pedicle Screw System - Class 2 Recall
Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended 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 thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis...
Source: Medical Device Recalls - September 23, 2014 Category: Medical Equipment Source Type: alerts

PIONEER SURGICAL TECHNOLOGY, INC. - Streamline - Class 2 Recall
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, ...
Source: Medical Device Recalls - September 10, 2014 Category: Medical Equipment Source Type: alerts

Alphatec Spine, Inc. - Solanas 2.1mm FIXED DEPTH DRILL, 10mm - Class 2 Recall
Solanas 2.1mm FIXED DEPTH DRILL, 10mm , Part No. 63928-10 The SOLANAS III Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3). It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (TI -T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization Sy...
Source: Medical Device Recalls - July 23, 2014 Category: Medical Equipment Source Type: alerts

SeaSpine Inc - Integra UCR 3mm Hex, Large Axial Driver. - Class 2 Recall
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", ...
Source: Medical Device Recalls - June 21, 2014 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Gibralt Polyaxial Screw - Class 2 Recall
Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2014 Category: Medical Equipment Source Type: alerts

Orthofix, Inc - Azure - Class 2 Recall
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., 3451 Plano Pkwy, Lewisville, TX 75056 USA. Tel: 1-888-298-5700/1-214-937-2000, RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy a...
Source: Medical Device Recalls - February 26, 2014 Category: Medical Equipment Source Type: alerts

Ebi, Llc - Biomet The Polaris Spinal System; Shortened Plug Driver - Class 2 Recall
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with dege...
Source: Medical Device Recalls - November 28, 2013 Category: Medical Equipment Source Type: alerts

Stryker Spine - Stryker Spine Torque Wrench - Class 2 Recall
Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterloateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment ...
Source: Medical Device Recalls - November 22, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trinica Anterior Lumbar Plate (ALP) system - Class 2 Recall
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 ...
Source: Medical Device Recalls - November 19, 2013 Category: Medical Equipment Source Type: alerts

Synthes USA HQ, Inc. - Synapse SD Drill Guide - Class 2 Recall
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlanto...
Source: Medical Device Recalls - July 30, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the dis...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the di...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the d...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the d...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the di...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the di...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the dis...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts