Spinal Elements, Inc recalls Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous…

Recall date

December 18, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0907-2015

FDA classification

Class II

Brand / firm

Spinal Elements, Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.