Z-0907-2015 Class II Terminated
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