FDAFDA · Food and drugs·Recall number Z-1879-2013
Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) 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.
Published August 14, 2013 · Recall initiated: June 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- 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.
- Lot
- 5450-851-000(Console 100V) S/N 1127900134, 1133400114, 1202400224, 1205800094, 1226800284, 1127900144, 1133400124, 1202400234, 1205800104, 1226800294, 1127900154, 1133400134, 1202400244, 1206200574, 1226800304, 1127900164, 1133400144, 1203700594, 1206200584, 1228500194, 1127900174, 1133400154, 1203700604, 1206200594, 1228500204, 1127900184, 1133900014, 1205100514, 1222800034, 1228500214, 1127900194, 1133900024, 1205100524, 1222800044, 01J0018, 1127900204, 1133900034, 1205100534, 1224800314, 02B0052, 1130500054, 1133900044, 1205100544, 1225500084, 02G0091, 1130500064, 1133900054, 1205100554, 1225500094, 05H0386, 1130500074, 1201300384, 1205100564, 1225500104, 1130500084, 1202400154, 1205100574, 1225500114, 1130800374, 1202400164, 1205100584, 1225500124, 1130800384, 1202400174, 1205100594, 1226800234, 1130800394, 1202400184, 1205100604, 1226800244, 1130800404, 1202400194, 1205800064, 1226800254, 1130800414, 1202400204, 1205800074, 1226800264, 1130800424, 1202400214, 1205800084, 1226800274.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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