CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

Spider Surgical Instrument: Flexible Clip Applier recalled

Transenterix is recalling Spider Surgical Instrument: Flexible Clip Applier The Spider¿ Surgical Instruments are, distributed nationwide in the US. The recall was initiated on 2 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled89 boxes(6 units per box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2137-2012
FDA event ID: 62583
Recalling firm: Transenterix, Morrisville, NC
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2012
FDA classified: 3 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

2 Jul 2012	Recall initiated by company
3 Aug 2012	Classified by FDA	+32 days
15 Aug 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland

Nationwide

Stores named: Walmart

Questions about this recall

Is Spider Surgical Instrument: Flexible Clip Applier The Spider¿ Surgical Instruments are recalled?

Yes. Transenterix recalled Spider Surgical Instrument: Flexible Clip Applier The Spider¿ Surgical Instruments are on 2 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2137-2012.

Why was it recalled?

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

Which lots 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.

Where was it sold?

Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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