Class II — Spinal Elements, Inc
| Recalling firm | Spinal Elements |
|---|---|
| Registered facility | SPINAL ELEMENTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 1200 units |
| Distribution | Nationwide Distribution |
| Initiated | 2014-12-18 |
| Classified | 2015-01-05 |
| Terminated | 2015-03-10 |
| Recall number | Z-0907-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spinal Elements, Inc (Z-0907-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70044/
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