Z-1880-2013 Class II Terminated
FDA device recall Z-1880-2013 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jun 24, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jan 30, 2014). Affected quantity: 215 units total.
Recall details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Jun 24, 2013
- Termination Date
- Jan 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215 units total
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1880-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026