Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to ...
FDA Recall #Z-0907-2015 — Class II — December 18, 2014
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.
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.
Recalling Firm
Spinal Elements, Inc — Carlsbad, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1200 units
Distribution
Nationwide Distribution
Code Information
All revisions
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated