Events

Recall of Device Recall Spinal Intervertebral body Fixation Orthosis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Captiva Spine, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61804
  • Event Risk Class
    Class 2
  • Event Number
    Z-1545-2012
  • Event Initiated Date
    2012-03-22
  • Event Date Posted
    2012-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109124
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    Captiva spine has initiated a correction of the smartlox instructions for use (ifu) for smartlox cervical plate system. the pre vacuum sterilization cycle [270 (132 c) for 3 minutes] has not been validated.
  • Action
    Captiva Spine sent a "VOLUNTARY CORRECTION NOTIFICATION" letter dated March 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides steps for the correction and a verification form for customers to complete. Customers should contact the firm at 877-772-5571 for questions concerning this notice.

Device

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

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