Spinal Elements, Inc: Medical Device Recall in 2015 - (Recall #: Z-0907-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 18, 2014

Date Posted: January 14, 2015

Recall Number: Z-0907-2015

Event ID: 70044

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.

Status: Terminated

Product Quantity: 1200 units

Code Information:

All revisions

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated