Cusa Excel Ultrasonic Surgical Aspirator System

• • Terminated Z-1522-2014 FDA Class II ·initiated 10 Mar 2014

  Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.

• • Terminated Z-0920-2013 FDA Class II ·initiated 7 Jan 2013 ·on shared 510(k) K981262

  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.

• • Terminated Z-1215-2012 FDA Unclassified (pre-2012) ·initiated 14 Oct 2011

  A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra's in-process requirements for release. It was discovered during in-process inspection that the max power reading exceeded the specification of 80 watts, causing the stroke range of the tip to exceed it required range by up a value up to 0.002 inches

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K981262 ↗

FDA Product Code

LFL

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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