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

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA. Quantity: 330 Lot/code info: UDI-DI: 00810076563190, Lot: DNI

UPC codes

00810076563190

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.