Z-0907-2015 Class II Terminated
FDA device recall Z-0907-2015 was initiated by Spinal Elements, Inc on December 18, 2014 and is designated Class II. 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 con… The recall status is terminated (terminated March 10, 2015). Affected quantity: 1200 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2015
- Initiation Date
- December 18, 2014
- Termination Date
- March 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200 units
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.
Distribution Pattern
Nationwide Distribution
Code Information
All revisions