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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62583
Product Type Devices
Status Ongoing
Recalling Firm Transenterix, Inc
City Morrisville
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-02
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDERĀ® Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization. Model Number: 9000029, Lot #DC301112, Exp. Date: Oct 2013; Lot #DC313111, Exp. Date: Nov 2013; Lot #DC061121, Exp. Date: Mar 2013; Lot #DC082122, Exp. Date: Feb 2014; Lot #DC168112, Exp. Date: Jun 2013; Lot #DC265111 Exp. Date: Sept 2013; Lot #DC341111, Exp. Date: Dec 2013; Lot #DC019125, Exp. Date: Jan 2014; Lot #DC061122, Exp. Date: Mar 2014; Lot #DC082121, Exp. Date: Feb 2014; Lot #DC102122, Exp. Date: Apr 2014; Lot #DC102123, Exp. Date: Apr 2014 and Lot #DC144121, Exp. Date: May 2014. Class II Some clip applier units may be inadequate to achieve clip closure. 89 boxes(6 units per box) Z-2137-2012