FDAClass IIAugust 15, 2012

SPIDER Surgical Instrument: Flexible Clip Applier The recall

SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical procedures for…

Why was SPIDER Surgical Instrument: Flexible Clip Applier The recalled?

Some clip applier units may be inadequate to achieve clip closure.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical procedures for…
Recalling firm
Transenterix, Inc
Quantity
89 boxes(6 units per box)
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls