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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64318
Product Type Devices
Status Ongoing
Recalling Firm Integra LifeSciences Corp.
City Plainsboro
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-07
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt, Emirates, Spain, Finland, France, Great Britian, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Japan, Korea (South), Kuwait, Lebanon, Sri Lanka, Latvia, Macedonia, Mexico, Malaysia, Netherlands, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Tunisia, Taiwan, United Arab, Viet Nam and South Africa.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. CEM Nosecone Catalogue No. C6623 Lot numbers: 1092855, 1093129, 1100436, 1100437, 1101217, 1101328, 1103393, 1104265, 1105067, 1110311, 1110892, 1112182, 1112183, 1114112, 1114655, 1115225, 1115499, 1115500, 1120771, 1121141, 1121142, 1121383, 1121627, 1122258, 1122259, 1123049 and 1130710. CEM Nosecone, Catalogue No. C6636: 1091431, 1091679, 1091680, 1093475, 1095103, 1095416, 1095417, 1100242, 1100434, 1100435, 1101094, 1101218, 1101219, 1103104, 1103395, 1103849, 1103849, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475, 1110476, 1110978, 1111490, 1111493, 1112187, 1112188, 1112212, 1113179, 1113180, 1113663, 1114357, 1114358, 1114659, 1114660, 1115039, 1115502, 1115504, 1115505, 1120776, 1120777, 1121167, 1121168, 1121169, 1121565, 1121566, 1121567, 1122344, 1123051, 1123052, 1123508, 1123511 and 1124053. Class II 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. USA 6,190, EU 22,972 and ROW 288 units Z-0920-2013
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