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.
FDA Recall Z-2327-2015 · Posted 2015-08-03
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Recalling FirmTITAN SPINE, LLC
Recall StatusTerminated
Product CodeOVE
Date Initiated2015-07-20
Date Terminated2015-10-20
Product Quantity137 units
Reason for Recall
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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