FDA-Device2014-08-13Class II
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Stryker Instruments Div. of Stryker Corporation
Hazard
The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
Sold states
Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI & WV.
Affected count
2,460 units
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2014Don't want to check this manually?
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