Events

Recall of CapLOX II Pedicle Screw System

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
    63633
  • Event Risk Class
    Class 2
  • Event Number
    Z-0413-2013
  • Event Initiated Date
    2012-09-20
  • Event Date Posted
    2012-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114524
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Reason
    Captiva spine recalled their caplox ii final torque driver, indicator due to the device prematurely breaking.
  • Action
    Captiva Spine contacted the customer by phone to have them return the device. For questions regarding this recall call 561-277-9480.

Device

CapLOX II Pedicle Screw System
  • Model / Serial
    Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution (Distributed to one customer located in MN)
  • Product Description
    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.
  • 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