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Integra LifeSciences Corp. recalls Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA
Recalled February 26, 2014 · FDA recall Z-0994-2014 · Integra LifeSciences
Hazard
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position. · FDA Class II
Units
17253 boxes
Sold at
Worldwide Distribution - USA Nationwide
Description
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
Product
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →