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TITAN SPINE, LLC recalls Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spi
Recalled August 12, 2015 · FDA recall Z-2327-2015 · TITAN SPINE
Hazard
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. · FDA Class II
Units
137 units
Sold at
Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Description
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Product
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.
Manufacturer(s)
TITAN SPINE, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →