Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Son...
FDA Device Recall #Z-1878-2013 — Class II — June 24, 2013
Recall Summary
| Recall Number | Z-1878-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 24, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Instruments Div. of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 215 units total |
Product Description
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) 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.
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
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.
Lot / Code Information
5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134, 1131900074, 1200500134, 1203200244, 1210100114, 1131300144, 1131900084, 1200500144, 1203200254, 1210100124, 1131300154, 1131900094, 1200500154, 1203200274, 1210100134, 1131300164, 1131900104, 1200500164, 1203700954, 1210100144, 1131300174, 1131900114, 1200500174, 1203700964, 1210100154, 1131300184, 1131900124, 1200500184, 1203700974, 1210700014, 1131300194, 1132800114, 1200500194, 1203900024, 1210700024, 1131300204, 1132800124, 1200500204, 1204000044, 1210700034, 1131300214, 1132800134, 1201300494, 1204000054, 1210700044, 1131300224, 1132800144, 1201300544, 1207400154, 1210700054, 1131300234, 1132800154, 1201300754, 1207400164, 1213800114, 1131300244, 1132800164, 1201300764, 1207400174, 1213800124, 1131900014, 1132800174, 1201300774, 1207400184, 1213800134, 1131900024, 1132800184, 1201300784, 1208300014, 1213800144, 1131900034, 1132800194, 1201300794, 1208300024, 1213800154, 1131900044, 1132800204, 1203200214, 1208300034, 1131900054, 1200500114, 1203200224, 1208300044, 1131900064, 1200500124, 1203200234, 1208300054.
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.