FDA Device recall Z-1880-2013
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical proced…
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical proced… by Stryker Instruments Div, citing 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. Th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1880-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-24 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | 5450-852-000 (Console 230V) with SN: 1134000114, 1206800484 1210900274, 1134000124, 1206800494, 1210900284,1134000134 1…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1880-2013%22
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