Reported Mar 20, 2013 · Terminated
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel +…
Integra LifeSciences Corp.
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: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
- Lot codes and dates
- CEM Nosecone Catalogue No
- C6623 Lot numbers
10928551093129110043611004371101217110132811033931104265110506711103111110892111218211121831114112111465511152251115499111550011207711121141112114211213831121627112225811222591123049 and 1130710. CEM NoseconeCatalogue No
- C6636
109143110916791091680109347510951031095416109541711002421100434110043511010941101218110121911031041103395110384911038491103850110385211039171103918110392211042571104263110507111104751110476111097811114901111493111218711121881112212111317911131801113663111435711143581114659111466011150391115502111550411155051120776112077711211671121168112116911215651121566112156711223441123051112305211235081123511 and 1124053
- Amount recalled
- USA 6,190, EU 22,972 and ROW 288 units
Why it was recalled
There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints.
This product could cause temporary or reversible health problems — stop using it.
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