Recall Z-0907-2015— Spinal Elements, Inc
Class II · Terminated
Class II FDA medical device recall by Spinal Elements, Inc, initiated 2014-12-18, terminated 2015-03-10. It names one FDA 510(k) clearance: K110632. 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..
- Recalling firm
- Spinal Elements, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-18
- Terminated
- 2015-03-10
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.