Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
FDA Recall Z-2156-2014 · Posted 2014-08-07
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeLFL
Date Initiated2014-06-24
Date Terminated2015-10-27
Product Quantity2,460 units
Reason for Recall
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.
Firm Action
The firm sent Medical Device Upgrade Notification letters dated July 11, 2014 to their customers.
Root Cause
Labeling design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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