Z-0907-2015Class II

Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with...

Name: Z-0907-2015 Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with...
Creator: Spinal Elements, Inc
Published: 2014-12-18
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2014-12-18 / Terminated / root cause: labeling and UDI

FDA source

Spinal Elements, Inc began a recall of Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have... on 2014-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0907-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-18
Posted: 2015-01-05
Terminated: 2015-03-10
Recalling firm: Spinal Elements, Inc
Product: 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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
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.
Quantity in commerce: 1200 units
Distribution: Nationwide Distribution
Product codes and lots: All revisions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0907-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0907-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05

Product code MAX

K110632Class IILucent or Lucent MagnumSpinal Elements, Inc. / cleared 2012-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)