Class 2 Device Recall CD HORIZON (R) LEGACY (TM) MAS

• Date Initiated by Firm: June 28, 2011
• Date Posted: July 25, 2011
• Recall Status: Terminated on December 24, 2012
• Recall Number: Z-2875-2011
• Recall Event ID: 59021
• 510(K)Number: K042025
• Product Classification: Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH - Product Code KWP
• Product: CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
• Code Information: Lot number H09E6272
• FEI Number: 1000477302
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Place; Memphis TN 38132
• For Additional Information Contact: Marybeth Thorsgaard; 901-396-3133 Ext. 4124
• Manufacturer Reason for Recall: Screws are longer then size etched on the screw.
• FDA Determined Cause: Other
• Action: Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011. For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.
• Quantity in Commerce: 199 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH, IN, MO, WI, MI, NY, IN, LA, MD, MA, NC, OR, NE WA, ID, CO, OR, UT, IL, WV, Canada, Singapore, Netherlands, Brazil, Columbia, Hong Kong, and Mexico.
• 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 = KWP