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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Sofamore Danek CD Horizon

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  Class 2 Device Recall Medtronic Sofamore Danek CD Horizon see related information
Date Initiated by Firm July 12, 2023
Date Posted August 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-2363-2023
Recall Event ID 92749
510(K)Number K140454  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Code Information SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200
Recalling Firm/
Medtronic Sofamor Danek USA, Inc
4340 Swinnea Rd
Memphis TN 38118-6603
For Additional Information Contact Christine Stewart
Manufacturer Reason
for Recall
Incorrect Laser Marking - Solera Awl Tip Tap
FDA Determined
Cause 2
Under Investigation by firm
Action Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignee on 07/12/2023 by UPS 2nd day mail. The notice explained the problem with the product, risk, and requested the following actions be taken immediately: "¿ Identify and quarantine any impacted product(s). ¿ Return all impacted product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. ¿ Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. ¿ This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records."
Quantity in Commerce 13 devices
Distribution US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
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 = OLO and Original Applicant = MEDTRONIC SOFAMOR DANEK USA, INC.