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U.S. Department of Health and Human Services

Class 2 Device Recall MULTIAXIAL SCREW

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  Class 2 Device Recall MULTIAXIAL SCREW see related information
Date Initiated by Firm November 30, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on April 05, 2012
Recall Number Z-0465-2012
Recall Event ID 60568
510(K)Number K042025  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132

implantation
Code Information Lot Numbers: 0154947W and 0163314W
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Marybeth Thorsgaard
901-396-1800
Manufacturer Reason
for Recall		 One screw may be longer then size etched on the screw.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 extension 3173
Quantity in Commerce 30 units
Distribution Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
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 = KWQ and Original Applicant = MEDTRONIC SOFAMOR DANEK, INC.
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