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    Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes***Contact Information: Captiva Spine Inc. 967 Alternate AA #1 Jupiter, FL 33477. Tel: 877-772-5571***CAPTIVA SPINE***". Intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code KWQ·March 22, 2012

    Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and I is Inserter. Products subject to recall: FuseLOX Lumbar Inserter Inserter - Part Number: FPT0200 Lot Number 6110100. Quantity distributed (8) is found in table on page 5 of 6. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for 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-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code MAX·April 27, 2012

    Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Trial products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and T is Trial. Products subject to recall: FuseLOX Lumbar Trials Trial - 7mm x 25mm Part Number: FPT2507 Lot Number 8110001. Trial - 8mm x 25mm Part Number FPT2508 Lot Number 8110002. Trial - 9mm x 25mm Part Number: FPT2509 Lot Number 8110003. Trial - 10mm x 25mm Part Number: FPT2510 Lot Number 8110004. Trial - 11mm x 25mm Part Number: FPT2511 Lot Number 8110005. Trial - 12mm x 25mm Part Number: FPT2512 Lot Number 8110006. Trial - 13mm x 25mm Part Number FPT2513 Lot Number 8110007. Trial - 14mm x 25mm Part Number FPT2514 Lot Number 8110008. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for 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-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code MAX·April 27, 2012

    Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: [email protected]***" FPL - F is FuseLOX, P is Plif, C is Lorditic Products subject to recall: FuseLOX Lumbar Lorditic: Lorditic - 7mm x 25mm Part Number: FPL2507 Lot Number 07110010. Lorditic - 8mm x 25mm Part Number FPL2508 Lot Number 07110011. Lorditic - 9mm x 25mm Part Number: FPL2509 Lot Number 07110012. Lorditic - 10mm x 25mm Part Number: FPL2510 Lot Number 07110013. Lorditic - 11mm x 25mm Part Number: FPL2511 Lot Number 07110014. Lorditic - 12mm x 25mm Part Number: FPL2512 Lot Number 07110015. Lorditic - 13mm x 25mm Part Number FPL2513 Lot Number 07110016. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for 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-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code MAX·April 27, 2012

    Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: [email protected]***" FPC - F is FuseLOX, P is Plif, C is Convex Products subject to recall: Convex - 7mm x 25mm Part Number: FPC2507 Lot Number 07110002. Convex - 8 mm x 25mm Part Number FPC2508 Lot Number 07110003. Convex - 9mm x 25mm Part Number: FPC2509 Lot Number 07110004. Convex - 10mm x 25mm Part Number: FPC2510 Lot Number 07110005. Convex - 11mm x 25mm Part Number: FPC2511 Lot Number 07110006. Convex - 12mm x 25mm Part Number: FPC2512 Lot Number 07110007. Convex - 13mm x 25mm Part Number FPC2513 Lot Number 07110008. Convex - 14mm x 25mm Part Number FPC2514 Lot Number 07110009. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for 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-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code MAX·April 27, 2012

    CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system 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 the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Captiva Spine, Inc·November 28, 2012

    Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).

    FDA Enforcement
    Class II ·Terminated·Captiva Spine, Inc·April 29, 2015

    CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system 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 the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code MNI·September 20, 2012

    Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code KWQ·November 22, 2011

    Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code KWQ·November 22, 2011

    Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code LXH·February 25, 2015