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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
SPIDER Surgical Instrument: Flexible Clip Applier		see related information
Date Posted August 03, 2012
Recall Number Z-2137-2012
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
Reason for
Recall		 Some clip applier units may be inadequate to achieve clip closure.
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
 
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