CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
Ti-Bond Marketing Literature/Labeling recalled by Spinal Elements
Spinal Elements is recalling Ti-Bond Marketing Literature/Labeling, distributed nationwide in the US. The recall was initiated on 18 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0907-2015
- FDA event ID
- 70044
- Recalling firm
- Spinal Elements, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2014
- FDA classified
- 5 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Dec 2014 | Recall initiated by company | |
| 5 Jan 2015 | Classified by FDA | +18 days |
| 14 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Ti-Bond Marketing Literature/Labeling recalled?
Yes. Spinal Elements recalled Ti-Bond Marketing Literature/Labeling on 18 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-0907-2015.
Why was it 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.
Which lots are affected?
All revisions
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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