FDAFDA · Food and drugs·Recall number Z-0125-2025
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Published October 23, 2024 · Recall initiated: August 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- XTANT Medical Holdings, Inc
- Distributor
- US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
- Lot
- UDI-DI: 00810076563190, Lot: DNI
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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