Z-0846-2024Class II

Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm...

Name: Z-0846-2024 Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm...
Creator: XTANT Medical Holdings, Inc
Published: 2023-11-28
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2023-11-28 / Open, Classified / root cause: manufacturing process

FDA source

XTANT Medical Holdings, Inc began a recall of Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length on 2023-11-28. FDA classified it as Class II and gives the reason as "Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm...". 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-0846-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-01-29
Recalling firm: Xtant Medical Holdings, Inc.
Product: Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/28/23 the recall notice was emailed. Customers with questions can call the firm at 1-406-924-5878 from 8 a.m. to 5 p.m. (Mountain Time).
Quantity in commerce: 6
Distribution: US distribution in MI.
Product codes and lots: UDI-DI: 00810076564005, Lot: AP23000143

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0846-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0846-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-29

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)