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Sources: EU EUDAMED, US FDA
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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", 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. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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 the thoracic, lumbar, and sacral spine.
FDA Enforcement
Class II
·Terminated·SeaSpine Inc·July 2, 2014
Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
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", 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. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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 the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine Inc·Product code NKB·May 21, 2014
Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009