Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
FDA Recall Z-0125-2025 · Posted 2024-10-17
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Recalling FirmXTANT Medical Holdings, Inc
Recall StatusOpen, Classified
Product CodeNKB
Date Initiated2024-08-21
Product Quantity330
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.
Firm Action
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 [email protected]
Root Cause
Process change control
Distribution Pattern
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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