Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use

FDA device recall Z-1880-2013 · posted 2013-08-06 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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

Action taken

Stryker sent an URGENT Medical Device Recall Notice letter dated June 24, 2013 to all affected customers. The letter identified the affected product, product issue, risk to health and actions to be taken. Customers were instructed to locate affected product and hold for upgrade, use enclosed response form to document inventory and receipt of notice, and in case of further distribution forward the recall notice. Stryker will dispatch a technician to perform the upgrade to the affected product. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Kara Spath, Regulatory Affairs 269-389-4518 kara.spath@stryker.com.

Root cause

Component change control

Status

Terminated

Product code

LFL

Quantity affected

215 units total

Distribution

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

Date initiated

2013-06-24

Date posted

2013-08-06

Date terminated

2014-01-30

Location

Portage, MI

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