Cortera Spinal Fixation Screw (XTANT) – Implant Marking Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Brand
XTANT Medical Holdings, Inc
Lot Codes / Batch Numbers
UDI-DI: 00810076563190, Lot: DNI
Products Sold
UDI-DI: 00810076563190, Lot: DNI
XTANT Medical Holdings, Inc is recalling Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 due to Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released man. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 8/21/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Examine affected devices and quarantine any screws with DNI markings. 2) Notify your staff about the recall. If affected devices were further distributed, provide the recall notice to these customers. 3) Complete and return the response forms via email to mdolan@xtantmedical.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026