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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description 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.
Recall Number Z-1880-2013
Classification Class II
Code Info 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.
Product Distributed Qty 215 units total
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 saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012.

Event Detail

Event Id 65486
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.