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U.S. Department of Health and Human Services

Class 2 Device Recall TiBond

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  Class 2 Device Recall TiBond see related information
Date Initiated by Firm December 18, 2014
Date Posted January 05, 2015
Recall Status1 Terminated 3 on March 10, 2015
Recall Number Z-0907-2015
Recall Event ID 70044
510(K)Number K110632  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
Code Information All revisions
Recalling Firm/
Manufacturer		 Spinal Elements, Inc
3115 Melrose Dr
Suite 200
Carlsbad CA 92010-6690
For Additional Information Contact
760-607-0121 Ext. 206
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = SPINAL ELEMENTS, INC.
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