FDA Device recall Z-0907-2015
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft
- FDA Device
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft by Spinal Elements, citing 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 u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0907-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-18 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinal Elements |
| Distribution | US |
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
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.
Identifiers
| code_info | All revisions |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0907-2015%22
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