XTANT recalls Cortera spinal screws marked 'DNI' due to potential inadequate strength if implanted. Affected units have UDI-DI: 00810076563190 and Lot: DNI. Contact for return instructions.
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.
XTANT is recalling spinal screws marked 'DNI' because they might not be strong enough if implanted. This could lead to complications during spinal surgery. Affected units have specific identifiers listed in the recall notice.
Screws marked 'DNI' were not intended for implantation and may not meet strength standards. If used in spinal surgery, they could fail under stress, risking injury or surgery complications.
Patients who received spinal surgery using these screws are most at risk. The recall applies to specific screw models sold with the DNI lot number.
Check for the UDI-DI code 00810076563190 and lot number DNI on the screw packaging. The screws are part of the Cortera Spinal Fixation System with specific dimensions.
Look for the UDI-DI code 00810076563190 and lot number DNI on the screw packaging.
The screws marked 'DNI' may not have been manufactured to the required strength standards for spinal implants.
Check for the UDI-DI code 00810076563190 and lot number DNI on the screw packaging.
The recall notice does not specify a remedy, so contact XTANT directly for further instructions.
We’ve drafted a message you can send XTANT to request your refund or repair — edit it as you like.
Subject: Recall Z-0125-2025 — XTANT XTANT Hello, I own a XTANT that is covered by recall Z-0125-2025 from XTANT. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
