Z-0125-2025Class II

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

Name: Z-0125-2025 Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Creator: XTANT Medical Holdings, Inc
Published: 2024-08-21
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2024-08-21 / Open, Classified / root cause: manufacturing process

FDA source

XTANT Medical Holdings, Inc began a recall of Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 on 2024-08-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0125-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-21
Posted: 2024-10-17
Recalling firm: Xtant Medical Holdings, Inc.
Product: Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA root cause: Process change control
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]
Quantity in commerce: 330
Distribution: US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Product codes and lots: UDI-DI: 00810076563190, Lot: DNI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0125-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17

Product code NKB

K221403Class IICortera Spinal Fixation SystemSurgalign Spine Technologies / cleared 2022-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)