Class 2 Device Recall Sonopet Ultrasonic Aspirator Console

• Date Initiated by Firm: June 24, 2013
• Date Posted: August 06, 2013
• Recall Status: Terminated on January 30, 2014
• Recall Number: Z-1880-2013
• Recall Event ID: 65486
• 510(K)Number: K010309
• Product Classification: Instrument, ultrasonic surgical - Product Code LFL
• Product: Sonopet Ultrasonic Aspirator Console; 5450-852-000 (Console 230V); ; Product Usage:; The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
• Code Information: 5450-852-000 (Console 230V) with SN: 1134000114, 1206800484 1210900274, 1134000124, 1206800494, 1210900284,1134000134 1206800504, 1210900294, 1134000144, 1206800514, 1210900304, 1134000154, 1206800524, 1211800064, 1134000164, 1206800534, 1211800074, 1134000174, 1206800544, 1211800084, 1134000184, 1208700014, 1211800094, 1134000194, 1208700024, 1212900014, 1134000204, 1208700034, 1213100114, 1201700324, 1208700044, 1213100124, 1201700334, 1208700054, 1213100134, 1201700344, 1209400164, 1213100144, 1201700354, 1209400174, 1213100154, 1201700364, 1209400184,1206500014, 1209400194, 1206500024, 1209400204, 1206500034, and 1210900264.
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kara Spath; 269-323-7700
• Manufacturer Reason for Recall: A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali
• FDA Determined Cause: Component change control
• Action: Stryker sent an URGENT Medical Device Recall Notice letter dated June 24, 2013 to all affected customers. The letter identified the affected product, product issue, risk to health and actions to be taken. Customers were instructed to locate affected product and hold for upgrade, use enclosed response form to document inventory and receipt of notice, and in case of further distribution forward the recall notice. Stryker will dispatch a technician to perform the upgrade to the affected product. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Kara Spath, Regulatory Affairs 269-389-4518 kara.spath@stryker.com.
• Quantity in Commerce: 215 units total
• Distribution: Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.
• 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 = LFL and Original Applicant = MUTOH AMERICA CO., LTD.