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XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Recalled October 23, 2024 · FDA recall Z-0125-2025 · XTANT Medical Holdings
Hazard
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance. · FDA Class II
Units
330
Sold at
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Description
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Product
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Manufacturer(s)
XTANT Medical Holdings, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →