FDA Enforcement
Class II
Terminated
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.
Recall: Z-2327-2015
·
Reported August 12, 2015
Enforcement
- Recall Number
- Z-2327-2015
- Event ID
- 71740
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- TITAN SPINE, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 12, 2015
- Initiation Date
- July 20, 2015
- Classification Date
- August 3, 2015
- Termination Date
- October 20, 2015
- Address
- 6140 W Executive Dr, Suite A, Mequon, WI, 53092-4499, United States
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
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Code Info
Lot numbers: V03, V05, V06
Distribution
Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Quantity
137 units