Z-2327-2015 Class II Terminated
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