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Recall Observatory FDA recall evidence

Device product

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

Z-0125-2025

August 21, 2024

Class II

Product summary

Firm
XTANT Medical Holdings, Inc
Event
Event 95395
Status
Ongoing
Classification
Class II
Quantity
330
Official record key
device-enforcement:Z-0125-2025

Official wording

Reason: 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.

Code information: UDI-DI: 00810076563190, Lot: DNI

Distribution pattern: US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.