Devices

Device Recall Spinal Intervertebral body Fixation Orthosis

Model / Serial
Serial Number: 002, 004, 007, 009, 011, 015, 017, 018, 019, 020, 024, 025, 035 and 030.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including the states of FL, IN, UT, GA, PA, TX, AL, NC, MI, and MN.
Product Description
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.
Manufacturer
Captiva Spine, Inc
1 Event
- Recall of Device Recall Spinal Intervertebral body Fixation Orthosis

Manufacturer

Captiva Spine, Inc

Manufacturer Address
Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
Manufacturer Parent Company (2017)
Captiva Spine Inc.
Source
USFDA

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