Z-2327-2015 Class II Terminated
FDA device recall Z-2327-2015 was initiated by TITAN SPINE, LLC on July 20, 2015 and is designated Class II. Reason for recall: Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. The recall status is terminated (terminated October 20, 2015). Affected quantity: 137 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2015
- Initiation Date
- July 20, 2015
- Termination Date
- October 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 137 units
Product Description
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.
Reason for Recall
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Distribution Pattern
Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Code Information
Lot numbers: V03, V05, V06