medical Class II Updated 2024-10-23

XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 4

Recalled Product

Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00810076563190, Lot: DNI
View official government recall

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