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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic CD HORIZON Spinal System MULTIAXIAL SCREW FOR 5.5/6.0MM RODS

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  Class 2 Device Recall Medtronic CD HORIZON Spinal System MULTIAXIAL SCREW FOR 5.5/6.0MM RODS see related information
Date Initiated by Firm July 09, 2018
Create Date August 03, 2018
Recall Status1 Terminated 3 on May 07, 2021
Recall Number Z-2603-2018
Recall Event ID 80541
510(K)Number K113174  
Product Classification Z-2603-2018 - Product Code NKB
Product Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045
Code Information lot 0648247W
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information Contact Eric Epperson
901-344-1435
Manufacturer Reason
for Recall		 This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
FDA Determined
Cause 2		 Employee error
Action Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees, delivered 09 July 2018. The notice stated provided a list of Loaner kits where the screws may also be found and provided the following instructions: " Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. Transmission of this Field Safety Notice: 1.) This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 2.) Please transfer this notice to other organizations on which this action has an impact. 3.) Please maintain a copy of this notice in your records."
Quantity in Commerce 47 units
Distribution US
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = MEDTRONIC SOFAMOR DANEK USA, INC.
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