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U.S. Department of Health and Human Services

Class 2 Device Recall SPIDER Surgical Instrument: Flexible Clip Applier

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 Class 2 Recall
SPIDER Surgical Instrument: Flexible Clip Applier
see related information
Date Posted August 03, 2012
Recall Status1 Terminated on February 27, 2013
Recall Number Z-2137-2012
Recall Event ID 62583
Premarket Notification
510(K) Number
K091697 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER® 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.
Code Information 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.
Recalling Firm/
Manufacturer
Transenterix, Inc
635 Davis Dr Ste 300
Morrisville, North Carolina 27560-7183
For Additional Information Contact Tammy B. Carrea
919-765-8420
Manufacturer Reason
for Recall
Some clip applier units may be inadequate to achieve clip closure.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action TransEnterix sent an Urgent Device Recall letter date July 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product, remove the affected product from their inventory and either return it or dispose of it to prevent usage. Customers were instructed to complete the attached Inventory Reconciliation Formand return the form even if they no longer have any affected units in their inventory. Customers were instructed to ship the affected product to TransEnterix using the enclosed shipping label. If returning a form only, they should e-mail to adunn@transenterix.com. For questions customers were instructed to call 1-888-879-4111. For questions regarding this recall call 919-765-8420.
Quantity in Commerce 89 boxes(6 units per box)
Distribution Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = TRANSENTERIX, INC.
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