Device product
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.
Z-2327-2015
Product summary
- Firm
- TITAN SPINE, LLC
- Event
- Event 71740
- Status
- Terminated
- Classification
- Class II
- Quantity
- 137 units
- Official record key
device-enforcement:Z-2327-2015
Official wording
Reason: Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Code information: Lot numbers: V03, V05, V06
Distribution pattern: Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Derived failure modes
-
Unknown
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.