Events

Recall of Device Recall Drill Bits for Cervical Plate 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
    61811
  • Event Risk Class
    Class 2
  • Event Number
    Z-1648-2012
  • Event Initiated Date
    2011-11-22
  • Event Date Posted
    2012-05-23
  • 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=109147
  • 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 is recalling the smartlox cervical plate components 12 & 14 mm drill bits, single barrel variable drill guides, and double barrel fixed drill guides. the components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. there is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime.
  • Action
    Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels. For questions customers should call 877-772-5571. For questions regarding this recall call 561-277-9480.

Device

Device Recall Drill Bits for Cervical Plate System
  • Model / Serial
    Lot Numbers: 89427-2 R & 89427-3-R
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
  • Product Description
    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.
  • 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