Events

Recall of Spinal Invervetebral Disc Space 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
    61925
  • Event Risk Class
    Class 2
  • Event Number
    Z-1786-2012
  • Event Initiated Date
    2012-04-27
  • Event Date Posted
    2012-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109506
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    Captiva spine, inc. initiated a recall of fuselox lumbar implants, trials, and inserters after fda advised the firm that there is inadequate support for implemented design changes to the cleared device pivotec lumbar interbody fusion device.
  • Action
    Captiva Spine sent a Voluntary Correction Notification letter dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and return affected devices. Customers were also instructed to complete and return a Tracking/Verification Form. For questions customers were instructed to call 877-772-5571. For questions regarding this recall call 561-277-9480.

Device

Spinal Invervetebral Disc Space Orthosis
  • Model / Serial
    Lot Number: 6110100.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide) including FL,TX, UT, and NJ.
  • Product Description
    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.
  • 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