Class 2 Device Recall SET SCREW RETAINING DRIVER

• Date Initiated by Firm: January 03, 2014
• Date Posted: January 30, 2014
• Recall Status: Terminated on May 16, 2014
• Recall Number: Z-0866-2014
• Recall Event ID: 67203
• Product Classification: Screwdriver - Product Code HXX
• Product: SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
• Code Information: TI13J01811
• FEI Number: 1000477302
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Place; Memphis TN 38132
• For Additional Information Contact: Eric Epperson; 901-344-1435
• Manufacturer Reason for Recall: The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
• FDA Determined Cause: Reprocessing Controls
• Action: The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014.
• Quantity in Commerce: 7 units
• Distribution: US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
• 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.