37 results
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42ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·July 1, 2015
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
FDA Recall
Terminated
·X Spine Systems Inc·Product code MNH·April 7, 2015
Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.
FDA Recall
Terminated
·X Spine Systems Inc·Product code MNH·March 24, 2009
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
FDA Recall
Terminated
·X Spine Systems Inc·Product code MNH·March 11, 2015
Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
FDA Recall
Terminated
·X Spine Systems Inc·Product code FZS·July 15, 2011
Calix T PEEK Lumbar System, TLIF Rasp
FDA Recall
Terminated
·X Spine Systems Inc·Product code MAX·May 17, 2016
Calix T PEEK Lumbar System, TLIF Trial
FDA Recall
Terminated
·X Spine Systems Inc·Product code MAX·May 17, 2016
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
FDA Recall
Terminated
·X Spine Systems Inc·Product code FZX·July 11, 2014
Calix P PEEK Lumbar System, PLIF Trial
FDA Recall
Terminated
·X Spine Systems Inc·Product code MAX·May 17, 2016
Calix P PEEK Lumbar System, PLIF Rasp
FDA Recall
Terminated
·X Spine Systems Inc·Product code MAX·May 17, 2016
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·April 29, 2015
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·August 13, 2014
Calix T PEEK Lumbar System, TLIF Trial
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·October 26, 2016
Calix P PEEK Lumbar System, PLIF Trial
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·October 26, 2016
Calix T PEEK Lumbar System, TLIF Rasp
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·October 26, 2016
Calix P PEEK Lumbar System, PLIF Rasp
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·October 26, 2016
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
FDA Enforcement
Class II
·Terminated·Custom Spine, Inc.·August 7, 2013
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·October 26, 2016
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
FDA Recall
Terminated
·Custom Spine, Inc.·Product code NKB·March 28, 2013
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 1, 2012