Device 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.
Z-0907-2015
Product summary
- Event
- Event 70044
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1200 units
- Official record key
device-enforcement:Z-0907-2015
Official wording
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.
Code information: All revisions
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.