Captiva Spine, Inc

Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.

Orthopedic Devices

2

Yes

Nationwide Distribution (Distributed to one customer located in MN)

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.

Lot Numbers: 1500705A, 06110041, 1500707A, 06110043, 1500708A, and 06110044

Orthopedic Devices

2

Yes

Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.

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.

Lot Numbers: 89427-2 R & 89427-3-R

Orthopedic Devices

2

Yes

Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.

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.

Serial Number: 002, 004, 007, 009, 011, 015, 017, 018, 019, 020, 024, 025, 035 and 030.

Orthopedic Devices

2

Yes

Nationwide Distribution including the states of FL, IN, UT, GA, PA, TX, AL, NC, MI, and MN.

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.

Lot Number: 6110100.

Orthopedic Devices

2

Yes

USA (nationwide) including FL,TX, UT, and NJ.

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.