Z-2137-2012Class II

SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in...

Name: Z-2137-2012 SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in...
Creator: Transenterix, Inc
Published: 2012-07-02
License: https://open.fda.gov/license/

Asensus Surgical, Inc. / initiated 2012-07-02 / Terminated / root cause: manufacturing process

FDA source

Transenterix, Inc began a recall of SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping... on 2012-07-02. FDA classified it as Class II and gives the reason as "Some clip applier units may be inadequate to achieve clip closure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2137-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2012-08-03
Terminated: 2013-02-27
Recalling firm: Asensus Surgical, Inc.
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Some clip applier units may be inadequate to achieve clip closure.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2137-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2137-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-03

Product code GCJ

K091697Class IISpider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015Transenterix, Inc. / cleared 2009-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)