Ti-Bond Marketing Literature/Labeling — Class II medical device recall Z-0907-2015
Terminated recall by Spinal Elements, Inc, reported 2015-01-14, distributed nationwide. Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions)
| Recall number | Z-0907-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spinal Elements, Inc, Carlsbad, CA, United States |
| Recall initiated | 2014-12-18 |
| Classified | 2015-01-05 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,200 units |
| Model numbers | LT10000, MP-14000 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0907-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.