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Terminated

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.

FDA Recall Z-0994-2014 · Posted 2014-02-20

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Date Initiated2013-12-05
Date Terminated2017-01-26
Product Quantity17253 boxes

Reason for Recall

The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.

Firm Action

Integra sent an Urgent: Medical Device Correction Letter/Acknowledgement Return Form dated December 5, 2013 via traceable courier to their customers. The notification: advises customers of the nature of the issue and how it could affect CEM Nosecone use, advises customers what to do if the issue occurs and requests customers complete and return the Acknowledgment Return Form. The form should be faxed to [email protected] or 1-609-275-9445. Any questions can be directed to customer service at 855-532-1723.

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide Distribution - USA Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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