Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cortera Spinal Fixation System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Cortera Spinal Fixation System see related information
Date Initiated by Firm November 28, 2023
Date Posted January 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-0846-2024
Recall Event ID 93738
510(K)Number K221403  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product Cortera 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 Contact Michele 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NKB and Original Applicant = Surgalign Spine Technologies
-
-