Events

Recall of Device Recall TiBond

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spinal Elements, 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
    70044
  • Event Risk Class
    Class 2
  • Event Number
    Z-0907-2015
  • Event Initiated Date
    2014-12-18
  • Event Date Posted
    2015-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132185
  • 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
    Spinal elements is recalling the ti-bond related brochures that includes lt-10000 and mp-14000 (all revisions) the content regarding the ti-bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications.
  • Action
    Spinal Elements sent an Urgent Field Action letter dated December 22, 2014, to all affected customers. The letter informed the customers to cease all distribution of the literature material. The letter informed the customers that the content regarding the Ti-Bond coating in the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. In addition to the customer notiification letter, it will include a list of claims related to the field action. The letter also informed customers of the actions to be taken. Customers were instructed to immediately examine their literature inventory, discontinue the use and /or distribution of the affected brochure, destroy all copies or send them back to: Spinal Elements, Inc. 3115 Melrose Drive Carlsbad, CA 92010 If product was further distributed customers should identify those customers and notify them at once. Customers were also instructed to complete and return the enclosed "Customer Response Form." For questions regarding this recall call 760-607-0121, ext 206. Customers with questions were instructed to contact Customer Service at 1-877-SPINALS, ext 213. Customers with questions were instructed to contact Customer Service at (877) SPINAL5 Ext 213.

Device

Device Recall TiBond
  • Model / Serial
    All revisions
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 || This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
  • Manufacturer
    Spinal Elements, Inc

Manufacturer

Spinal Elements, Inc
  • Manufacturer Address
    Spinal Elements, Inc, 3115 Melrose Dr, Suite 200, Carlsbad CA 92010-6690
  • Source
    USFDA