FDA Enforcement
Class II
Terminated
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.
Recall: Z-0907-2015
·
Reported January 14, 2015
Enforcement
- Recall Number
- Z-0907-2015
- Event ID
- 70044
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Spinal Elements, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 14, 2015
- Initiation Date
- December 18, 2014
- Classification Date
- January 5, 2015
- Termination Date
- March 10, 2015
- Address
- 3115 Melrose Dr, Suite 200, Carlsbad, CA, 92010-6690, United States
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
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 Info
All revisions
Distribution
Nationwide Distribution
Quantity
1200 units