Recall Z-2327-2015 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
TITAN SPINE, LLC
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
| Date | Aug 3, 2015 (initiated Jul 20, 2015) |
| Status | Terminated |
| Reason | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. |
| Root cause | Nonconforming Material/Component |
| Action | Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. The letters described the problem and the product involved in the recall. Advised consignees to complete and return the enclosed response form. For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. Distributors were advised to examine their inventory and quarantine the product. If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information. |
| Quantity | 137 units |
| Distribution | Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142940 | Endoskeleton TCS System Titan Spine, LLC, Jan 28, 2015 |