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U.S. Department of Health and Human Services

Class 2 Device Recall Cortera Spinal Fixation System

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 Class 2 Device Recall Cortera Spinal Fixation Systemsee related information
Date Initiated by FirmNovember 28, 2023
Date PostedJanuary 29, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0846-2024
Recall Event ID 93738
510(K)NumberK221403 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductCortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Code Information UDI-DI: 00810076564005, Lot: AP23000143
Recalling Firm/
Manufacturer		 XTANT Medical Holdings, Inc
664 Cruiser Ln
Belgrade MT 59714-9719
For Additional Information ContactMichele Dolan
406-813-4145
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 Commerce6
DistributionUS distribution in MI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NKB
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