Class 2 Device Recall POWEREASE(TM) Instruments Set Screw Breakoff Instrument

• Date Initiated by Firm: December 03, 2014
• Date Posted: January 12, 2015
• Recall Status: Terminated on September 24, 2015
• Recall Number: Z-0952-2015
• Recall Event ID: 70032
• 510(K)Number: K111520
• Product Classification: Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
• Product: POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
• Code Information: Lot # - CA14C107
• 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: Process design
• Action: Medtronic sent an Urgent - Voluntary Market Removal letter dated December 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please remove the product from normal storage locations. Do not use this product. 2.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product. Alternatively, you may call Medtronic's Global Quality Department at (800) 876 -3133, extension 3197 for assistance If you need assistance or have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or the Global Quality Department at (800) 876 - 3133, extension 3197. We sincerely apologize for this inconvenience, but this action is necessary to assure that our high standard of quality is maintained.
• Quantity in Commerce: 24 units
• Distribution: US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
• 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 = HWE