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 ATEC Lateral Navigation Disc Prep Instruments

  • 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 ATEC Lateral Navigation Disc Prep Instrumentssee related information
Date Initiated by FirmJanuary 02, 2026
Date PostedFebruary 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1343-2026
Recall Event ID 98251
510(K)NumberK223765 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Code Information Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693
FEI Number 2027467
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad CA 92008-6505
For Additional Information ContactMichael Hendrickson
760-356-6777
Manufacturer Reason
for Recall		Due a design issue where the navigated array connection geometry is incorrect.
FDA Determined
Cause 2		Device Design
ActionOn 01/02/2026, the firm emailed an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" Letter to customers informing them that Alphatec Spine has been notified of complaints regarding LIF Navigated Osteotome instruments appearing to have incorrect orientation when used with the Medtronic StealthStation". The instrument is correctly identified and displays the correct navigated length; however, the projected image on the Medtronic StealthStation" is rotated by 90. Customers are instructed to: "Review their inventory to determine if any of these affected devices are in their possession. If a device is within their possession, abstain from use and return the device to Alphatec Spine using the attached return label. "Share this notice within their organization or any organization where the affected device(s) has (have) been transferred. "Fill out the last page of this letter to confirm that they have read this notification and have taken all necessary actions, as described in this notification. For any questions/concerns or require assistance with the recall, e-mail QMSCompliance@atecspine.com or call 1-800-922-1356.
Quantity in Commerce15 units
DistributionU.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
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 = OLO
-
-