FDAJuly 20, 2015device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
What to do
FDA enforcement status: Terminated
Brands named
titan spinetitan
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDATOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.2025-07-16
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