Reported Aug 13, 2014 · Terminated
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Stryker Instruments Div. of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
- Lot codes and dates
- Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s:& 1414600124.
2,459 of 2,459 codes
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
- Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s:
- Amount recalled
- 2,460 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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