Recall Z-0920-2013— Integra LifeSciences Corp.

Name: FDA recall Z-0920-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-07

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2013-01-07, terminated 2013-08-06. It names one FDA 510(k) clearance: K981262. Product: 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.. Reason: 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..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-01-07
Terminated: 2013-08-06
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K981262 — CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMValleylab, Inc.·cleared 1998-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.